Identity
- Trade Name
- AngioJet® Distaflex™ FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- Thrombectomy Set FDA UDI
- Model / Reference
- 111304-001 FDA UDI
- Description
- Thrombectomy Set FDA UDI
Identifiers
- Catalog Number
- 111304 FDA UDI
- Primary DI / UDI-DI
- 08714729889786 FDA UDI
- PMA Number
- P980037 FDA UDI
- FDA Product Code
- MCX FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thrombectomy suction catheter
AngioJet® Distaflex™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thrombectomy suction catheter.
- Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
- Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
- Symphony™ Advance™ Long Dilator — IMPERATIVE CARE INC. · Class II
- Indigo System — PENUMBRA, INC. · Class II
- Penumbra System — PENUMBRA, INC. · Class II
- Trevo — Stryker Corp.
- Penumbra System — PENUMBRA, INC. · Class II
- Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Cleared under the same submission
P980037 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 2bcd4caf-08b5-47d9-8677-24ed26de6a9e 35 fields · synced May 30, 2026