DRAP REGISTERED MEDICAL DEVICE
Scepter XC Occlusion Balloon Catheter (Intravascular Occlusion Balloon Catheter) [BC0411XC] is registered with DRAP under number MDIR-0005460 as a Class D (high risk) medical device, imported. The listed holder is Intek Corporation. It is listed as valid until 23 Aug 2028.
Screening result
MDIR-0005460 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
ELI-00034
| Device | Scepter XC Occlusion Balloon Catheter (Intravascular Occlusion Balloon Catheter) [BC0411XC] |
|---|---|
| Class | D |
| Listed holder | Intek Corporation |
| Holder address | Office. 517, Kohistan Towers, Mehfooz Road, Saddar, Rawalpindi. |
| Manufacturing site | M/s Micro Vention, Inc 1311 Valencia Avenue Tustin, California 92780, USA. |
| Issued | 24 Aug 2023 |
| Renewal date | 23 Aug 2028 |
| Licence | ELI-00034 |
Specifications
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Screened 5 Oct 2026, 21:32 (Pakistan time). A screening aid, not an official DRAP verification.
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| MDIR-0000247 | ERIC TM Retrieval Device | Class D |
| MDIR-0000383 | MemoPart TM Ventricular Septal Defect (VSD) Occluder | Class D |
| MDIR-0000384 | MemoPart TM Atrial Septal Defect (ASD) Occluder | Class D |
| MDIR-0000385 | MemoPart TM Occluder Delivery System | Class D |
| MDIR-0000386 | MemoPart TM Patent Ductus Arterious (PDA) Occluder | Class D |
| MDIR-0000387 | Figulla Flex II ASD Occluder | Class D |
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.