← Back to catalogue
Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire, Chocolate Pta …
FDA 510(k)Class II (US FDA 510(k))
510(k) K122070
Identifiers
- 510(k) Number
- K122070 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire, Chocolate Pta … by Trireme Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k)
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 | K122070 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trireme Medical, Inc.
Sources (1)
- FDA 510(k) K122070 24 fields · synced Jun 18, 2026