← Back to catalogue
A1-A, Abp, B, Mbp, Lead Connectors +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K970388
Identifiers
- 510(k) Number
- K970388 FDA 510(k)
- FDA Product Code
- DTD FDA 510(k)
- Models / Variants
- A1-A, Abp, B, Mbp, Lead Connectors FDA 510(k)Peh Adapter Sleeve FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3620 FDA 510(k)
- Regulation Number
- 870.3620 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- PT FDA 510(k)
A1-A, Abp, B, Mbp, Lead Connectors +1 more model by Biotronik, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS
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 | K970388 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K970388 24 fields · synced Jun 18, 2026