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AngioSculpt® PTCA Scoring Balloon Catheter
FDA UDIFDA 510(k)Class III (US FDA UDI)
510(k) K050629
Identity
- Trade Name
- AngioSculpt® PTCA Scoring Balloon Catheter FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Model / Reference
- 2027-2510 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M3702027251017 FDA UDI
- FDA Product Code
- NWX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic 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: Coronary angioplasty balloon catheter, basic
AngioSculpt® PTCA Scoring Balloon Catheter by Angioscore, Inc. — Class III — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050629 | Class III | Active |
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Manufacturer
- Manufacturer
- Angioscore, Inc.
Sources (2)
- FDA UDI 46d72ba6-7032-4f91-aa45-bdf0e0e2f55c 56 fields · synced Jun 18, 2026
- FDA 510(k) K050629 1 fields · synced May 29, 2026