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Medical device registration holder

Intek Corporation

94 DRAP registrations and enlistments (3 Class A, 9 Class B, 1 Class C, 81 Class D) · Screen a DRAP number · Device types · Companies

DRAP lists

All devices of Intek Corporation

DRAP no.DeviceClassStatus
MDIR-0004813Accuforce PTCA Balloon Dilatation CatheterDValid to Feb 2028
MDIR-0000244Angio-Seal VIP Vascular Closure Device AngioSeal VIP 610132 6Fr AngioSeal VIP 610133 8FrDRenewal passed
MDIR-0001400BIB Stent Placement CatheterDRenewal passed
MDIR-0007393BOBBY BALLOON CATHETER. Balloon Guide Catheter [BOB- 895]DValid to Nov 2029
MDIR-0000393CASPER TM RX Carotid Artery Stent SystemDRenewal passed
MDIR-0000246CHAPERON Guiding Catheter SystemDRenewal passed
MDIR-0001144Combo Plus Dual Therapy Stent Delivery System [Stent Delivery System]DRenewal passed
MDIR-0001401Covered CP StentDRenewal passed
MDIR-0001399CP Stent (Sterile Cheatham Platinum Stent)DRenewal passed
MDIR-0000390Crusade Bilumen CatheterDRenewal passed
MDIR-0001653Destination Carotid Guiding SheathDRenewal passed
MDIR-0003317EmPro Embolic Protection System [EP4514C-190 EP6514C-190]DValid to Mar 2027
MDIR-0000247ERIC TM Retrieval DeviceDRenewal passed
MDIR-0000387Figulla Flex II ASD OccluderDRenewal passed
MDIR-0003315Figulla Flex II PFO Occluder [18PFO25S, 19PFO18D 19PFO25D, 19PFO30D 19PFO35D]DValid to Mar 2027
MDIR-0002795Finecross MG (Coronary Micro-Guide Catheter)DRenewal passed
MDIR-0004811FRED Jr, Flow Re-Direction Endoluminal Device (Intracranial Neuro Vascular stent)DValid to Feb 2028
MDIR-0000394FRED TM (Flow Re-Direction Endoluminal Device)DRenewal passed
MDIR-0007395FRED X, Flow Re-Direction Endoluminal Device. Intracranial Neuro Vascular StentDValid to Nov 2029
MDIR-0006314Gusta (PTCA NC Balloon Dilatation Catheter)DValid to Feb 2029
MDIR-0001136Headway 17 Advanced MicrocatheterDRenewal passed
MDIR-0001133Headway 17 Advanced Soft MicrocatheterDRenewal passed
MDIR-0001134Headway 21 MicrocatheterDRenewal passed
MDIR-0001135Headway 27 MicrocatheterDRenewal passed
MDIR-0001140Headway Duo MicrocatheterDRenewal passed
MDIR-0003569Heartrail II (Guiding Catheter)DValid to Jun 2027
MDIR-0005767LomiFlow (Paclitaxel Eluting Coronary Balloon Dilatation Catheter)DValid to Nov 2028
MDIR-0007394LVIS EVO, Low Profile Visualized Intraluminal Support Device. Intracranial Neuro vascular StentDValid to Nov 2029
MDIR-0000245LVIS Intraluminal Support DeviceDRenewal passed
MDIR-0004812LVIS Jr Low Profile Visualised Intraluminal Support Device (Intracranial Neurovascular stent)DValid to Feb 2028
MDIR-0003313MemoPart PFO OccluderDValid to Mar 2027
MDIR-0003310MemoPart Snare [Sizes: Snare-15, Snare-20]DValid to Mar 2027
MDIR-0000384MemoPart TM Atrial Septal Defect (ASD) OccluderDRenewal passed
MDIR-0000385MemoPart TM Occluder Delivery SystemDRenewal passed
MDIR-0000386MemoPart TM Patent Ductus Arterious (PDA) OccluderDRenewal passed
MDIR-0000383MemoPart TM Ventricular Septal Defect (VSD) OccluderDRenewal passed
MDIR-0001137Microplex Coil System MCS-CS (18) Microplex Cosmos (18 System)DRenewal passed
MDIR-0001138Microplex Coil System MCS-CSSR (10) Microplex Cosmos (10 System)DRenewal passed
MDIR-0001129Microplex Helical Coils (10 System) (Neuro Vascular Embolization Coils)DRenewal passed
MDIR-0001139Microplex Platinium Compass Framing Coils (10 System) (Neuro Vascular Embolization Coils)DRenewal passed
MDIR-0001130Microplex Platinum Helical Coil Soft (10 System) (Neuro Vascular Embolization Coils)DRenewal passed
MDIR-0001132Microplex Platinum Helical Coils Regular (10 System) (Neuro Vascular Embolization Coils)DRenewal passed
MDIR-0000388Occlutech Delivery SystemDRenewal passed
MDIR-0001111Occlutech Muscular VSD OccluderDRenewal passed
MDIR-0001110Occlutech PDA OccluderDRenewal passed
MDIR-0003314Occlutech Sizing Balloon [53SB254, 53SB355]DValid to Mar 2027
MDIR-0004583Partner Sirolimus Eluting Stent System [Drug Eluting Stent System]DValid to Jan 2028
MDIR-0000395PBMV Balloon Catheters SetsDRenewal passed
MDIR-0000392PHIL TM Liquid Embolic SystemDRenewal passed
MDIR-0001131Platinum Helical Coils Hypersoft (10 System) (Neuro Vascular Embolization Coils)DRenewal passed
MDIR-0003567Progreat (Angiographic MicroCatheter Catheter)DValid to Jun 2027
MDIR-0001402PTS-X Sizing Balloon CatheterDRenewal passed
MDIR-0001654Radifocus Glidecath (Angiographic Catheter)DRenewal passed
MDIR-0002430Radifocus Guide Wire MDRenewal passed
MDIR-0001655Radifocus Introducer II (Trans-radial Kit)DRenewal passed
MDIR-0006677Radifocus Optitorque (Angiography Diagnostic Catheter)DValid to Apr 2029
MDIR-0002431RADIFOCUS OPTITORQUE CatheterDRenewal passed
MDIR-0002793Radifoucus Glidewire Advantage (Glidewire catheter)DRenewal passed
MDIR-0002794Runthrough NS (PTCA Guide wire)DRenewal passed
MDIR-0003316Ryueri PTCA Balloon Dilatation CatheterDValid to Mar 2027
MDIR-0003568Ryujin Plus (PTCA Dilatation Catheter)DValid to Jun 2027
MDIR-0003387Sapphire II NC Coronary Dilatation CatheterDValid to May 2027
MDIR-0003386Sapphire II PRO Coronary Dilatation CatheterDValid to May 2027
MDIR-0007396SCEPTER Mini Occlusion Balloon Catheter Intravascular Occlusion Balloon Catheter [BC0210M]DValid to Nov 2029
MDIR-0005460Scepter XC Occlusion Balloon Catheter (Intravascular Occlusion Balloon Catheter) [BC0411XC]DValid to Aug 2028
MDIR-0000391SCEPTOR C Occlusion Balloon CatheterDRenewal passed
MDIR-0003312Scoreflex NC Coronary Dilatation CatheteDValid to Mar 2027
MDIR-0001141SOFIA PLUS Percutaneous Catheter (Distal Access + Aspiration)DRenewal passed
MDIR-0001143Teleport MicroCatheter (Micro Catheter)DRenewal passed
MDIR-0003636Temporary transvenous pacing electrodeDValid to Aug 2027
MDIR-0000389Thrombuster IIDRenewal passed
MDIR-0001142Traxcess 14 Guidewire [GW1420040]DRenewal passed
MDIR-0001403Tyshak II PVT Catheter (Tyshak II PTV Catheter)DRenewal passed
MDIR-0001404Tyshak-Mini PTV Catheter (Valvuloplasty Catheter)DRenewal passed
MDIR-0001658Tyshak-X PTV CatheterDRenewal passed
MDIR-0003145Ultimaster Sirolimus Eluting Coronary Stent SystemDRenewal passed
MDIR-0004814Ultimaster Tansei Sirolimus Eluting Coronary Stent SystemDValid to Feb 2028
MDIR-0004815VIA MICROCATHETERDValid to Feb 2028
MDIR-0004816WEB SL Aneurysm Embolization System [Aneurysm Embolization System]DValid to Feb 2028
MDIR-0001657Z-5 Atrioseptostomy CatheterDRenewal passed
MDIR-0001656Z-MED II-X PTV CatheterDRenewal passed
MDIR-0006880Jade PTA Balloon Dilatation Catheter (Balloon Dilatation Catheter)CValid to Apr 2029
MDIR-0003085ANGIOWAY MANIFOLDBValid to Dec 2026
MDIR-0001405Brilliant Introducer KitBRenewal passed
MDIR-0001652DVILL Introducer (Introducer)BRenewal passed
MDIR-0004582ENDO-GUIDE (PTA Balloon Catheter)BValid to Jan 2028
MDIR-0001406Lepu Medical-Contrast Medium Injection Manifold KitsBRenewal passed
MDIR-0001408Lepu Medical-Inflation Device KitBRenewal passed
MDIR-0005461Radifocus Introducer II (Introducer Sheath)BValid to Aug 2028
MDIR-0001407SHOOCIN INTRODUCER KITBRenewal passed
MDIR-0003311V-Grip Detachment Controller [VG501]BValid to Mar 2027
MDIE-0000649Rayband Radial Artery Compression TourniquetAValid to Feb 2028
MDIE-0000727Runthrough NS Extension Wire (Extension Wire) [TW-JJ415]AValid to Aug 2028
MDIE-0000726TR Band (Radial Artery Hemostasis Band) [XX RF06, XX RF06L]AValid to Aug 2028

Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.