Identity
- Trade Name
- Impact™ FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- IMPACT BALLOON CATHETER 14MMX2CMX120CM FDA UDI
- Model / Reference
- 142120 FDA UDI
- Description
- IMPACT BALLOON CATHETER 14MMX2CMX120CM FDA UDI
Identifiers
- Catalog Number
- 142120 FDA UDI
- Primary DI / UDI-DI
- 04046964290763 FDA UDI
- 510(k) Number
- K931009 FDA UDI
- FDA Product Code
- KNQ FDA UDILIT FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 FDA UDI870.1250 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: Peripheral angioplasty balloon catheter, basic
Impact™ by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K931009 also covers:
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
- TYSHAK II® — B BRAUN INTERVENTIONAL SYSTEMS, INC
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 II | Pending data |
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Manufacturer
- Manufacturer
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI e6e77d16-6171-4832-98a9-fbd9cd078b00 37 fields · synced Jun 6, 2026