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Medical device registration holder

ACP Systems

79 DRAP registrations and enlistments (24 Class A, 16 Class B, 6 Class C, 33 Class D) · Screen a DRAP number · Device types · Companies

DRAP lists

All devices of ACP Systems

DRAP no.DeviceClassStatus
MDIR-0006957Bicarbon Fitline LFA Aortic (Aortic Mechanical Valve)DValid to Jun 2029
MDIR-0006958Bicarbon Fitline LFM Mitral (Mitral Mechanical Valve)DValid to Jun 2029
MDIR-0006960Bicarbon Overline Aortic (Mechanical heart Valve)DValid to Jun 2029
MDIR-0006959Bicarbon Slimline LSA Aortic (Aortic Mechanical Valve)DValid to Jun 2029
MDIR-0006967Carbomedics Optiform Mitral (Mitral Mechanical Bileaflet valves)DValid to Jun 2029
MDIR-0006965Carbomedics Orbis Aortic (Aortic Mechanical Bileaflet valves)DValid to Jun 2029
MDIR-0006966Carbomedics Orbis Mitral (Mitral Mechanical Bileaflet valves)DValid to Jun 2029
MDIR-0006963Carbomedics Reduced Aortic (Aortic Mechanical Bileaflet valves)DValid to Jun 2029
MDIR-0006961Carbomedics Standard Aortic (Aortic Mechanical Bileaflet valve)DValid to Jun 2029
MDIR-0006962Carbomedics Standard Mitral (Mitral Mechanical Bileaflet valves)DValid to Jun 2029
MDIR-0006964Carbomedics Supra-Annular Aortic(Top Hot) (Aortic Mechanical Bileaflet valves)DValid to Jun 2029
MDIR-0000770Clip 9 Vitalitec (Titanium Hemostatic Clip)DRenewal passed
MDIR-0000768COR-KNOT DEVICE Kit (030925, HTS:9018.90)DRenewal passed
MDIR-0000767COR-KNOT QUICK LOAD 6-Pouch (030902, HTS:9018.90)DRenewal passed
MDIR-0000969COR-KNOT QUICK LOAD MINI DEVICE (PNs 0314-00 and 031450)DRenewal passed
MDIR-0000769COR-KNOT QUICK LOAD Single (030950, HTS:9018.90)DRenewal passed
MDIR-0004823FIREHAWK Rapamycin Target Eluting Coronary Stent SystemDValid to Feb 2028
MDIR-0003847FOXTROT NC PTCA Balloon Catheter.DValid to Oct 2027
MDIR-0003848FOXTROT PRO PTCA Balloon Catheter.DValid to Oct 2027
MDIR-0000971HeartMate 3 Apical Cuff-[106522INT] left ventricular assist systemDRenewal passed
MDIR-0000970HeartMate II Sealed Outflow Bend Relief Collar -107315DRenewal passed
MDIR-0000771SLS-CLIP Vitalitec (Titanium Hemostatic Clip)DRenewal passed
MDIR-0008601Surge ALPINE Femoral Venous CannulaDValid to Mar 2030
MDIR-0008603Surge Antegrade Cardiopledgia CannulaDValid to Mar 2030
MDIR-0008605Surge Cardiac SuckersDValid to Mar 2030
MDIR-0008693Surge Coronary Artery Retraction ClipsDValid to Apr 2030
MDIR-0008602Surge PEAK Left Ventricular Vent CannulaDValid to Mar 2030
MDIR-0008600Surge Perfusion Cannula/ Vessel CannulaDValid to Mar 2030
MDIR-0008607Surge Retrograde Cardioplegia Cannula (Manual Inflate)DValid to Mar 2030
MDIR-0008608Surge Retrograde Cardioplegia Cannula (Self Inflate)DValid to Mar 2030
MDIR-0000973Thoratec HeartMate 3 LVAS Implant Kit-106524US/ (106524INT)DRenewal passed
MDIR-0000974Thoratec HeartMate 3 Outflow Graft with Bend Relief105581US/ [105581INT]DRenewal passed
MDIR-0000972Thoratec HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts)-106015 (106016)DRenewal passed
MDIR-0002823CT-0701 Instrument Tray, CT-1010 (Mitral Valve Exposure System)CRenewal passed
MDIR-0002822CT-0702 Instrument Tray, CT-1000 (Ultra Vision Retractor Set)CRenewal passed
MDIR-0003376EP-Tracer 102 (Electrophysiologic measurement system)CValid to May 2027
MDIR-0004824EP-Tracer 70 (Electrophysiologic measurement system)CValid to Feb 2028
MDIR-0008609MicroSurge BlowMisterCValid to Mar 2030
MDIR-0008604Surge Perfusion SetsCValid to Mar 2030
MDIR-0009766Cor - Knot MICRO DeviceBValid to Jul 2030
MDIR-0009542CygNet - Flexible Vascular ClampsBValid to Jun 2030
MDIR-0009543Greyhound Adjustable Spring ClipsBValid to Jun 2030
MDIR-0002871I.Q Guidewire PTFE Coated (urology guidewire)BRenewal passed
MDIR-0002872I.Q Hemostasis Valve Y-ConnectorBRenewal passed
MDIR-0002873I.Q Hydrophilic Coated Introducer Sheath Kit and accessoriesBRenewal passed
MDIR-0002874I.Q Inflation DeviceBRenewal passed
MDIR-0003052I.Q Introducer Sheath Kit and accessories [00011, 00012, 00013, 00014, 00015, 00016, 00017, 00018,…BValid to Dec 2026
MDIR-0002875I.Q ManifoldBRenewal passed
MDIR-0009767InTrack Ultra Insert SetsBValid to Jul 2030
MDIR-0009548Microcure Disposable Incision Protection Sleeve (Type A)BValid to Jun 2030
MDIR-0009549Microcure Disposable Incision Protection Sleeve (Type B)BValid to Jun 2030
MDIR-0008606Surge Cardiac Insulation PadsBValid to Mar 2030
MDIR-0009583WEXLER MIS ForcepsBValid to Jun 2030
MDIR-0009584WEXLER Multi-Purpose ClampsBValid to Jun 2030
MDIR-0009585WEXLER VATS ScissorsBValid to Jun 2030
MDIE-000004014 Volt Li-Ion Battery Set-2456ARenewal passed
MDIE-0000310Appliers for VITALITEC Hemostatic ClipsARenewal passed
MDIE-0000276Bard-Parker handleARenewal passed
MDIE-0000035Consolidated Bag-Pocket Controller 14V Battery, Right -104233 (Accessories used for Heartmate II (LVAS)ARenewal passed
MDIE-0000337CT-0705 Instrument Tray, CT-1705 (CT Lift System)AValid to Dec 2026
MDIE-0000272DeBakey Forceps Surgical Reusable (non Sterile) InstrumentsARenewal passed
MDIE-0000038Heart Mate 14 Volt Li-Ion Battery Clip Set2865ARenewal passed
MDIE-0000039HeartMate 3 LVAS System Controller with EBB 106531US/ (106531INT)ARenewal passed
MDIE-0000282Metzenbaum ScissorsARenewal passed
MDIE-0000274MIS Clip ApplierARenewal passed
MDIE-0000278MIS Needle HoldersARenewal passed
MDIE-0000275MIS ScissorsARenewal passed
MDIE-0000033Mobile Power Unit-107754/ (107758)/(107758UK) (Accessories used for Heartmate II (LVAS)ARenewal passed
MDIE-0000277Multi-Purpose ClampsARenewal passed
MDIE-0000336Rising Band Radial Air Bag Hemostasis Compressor [ZXD-I]AValid to Dec 2026
MDIE-0000034Shower Bag ( Pocket Controller) -104232 (Acessories (Paitent Wearable)ARenewal passed
MDIE-0001594Surge TourniquetsAValid to Apr 2030
MDIE-0001593Surge Tubing OrganizerAValid to Apr 2030
MDIE-0000273Thoracoscopic Knot Tier/PusherARenewal passed
MDIE-0000037Thoratec Heart Mate II System Controller (Pocket Controller with EBB)-106762 (106017)ARenewal passed
MDIE-0000036Universal Battery Charger -1440 (103869) External Component used for Heartmate II (LVAS)ARenewal passed
MDIE-0000280VATS ForcepsARenewal passed
MDIE-0000279Yasargil-Type Applying ForcepsARenewal passed
MDIE-0000281Yasargil-Type Occlusion ClipARenewal passed

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