← Back to catalogue
Heparin Coated Miniature Centrifugal Bypass Pump System +1 more model
FDA 510(k)Class II (US FDA 510(k))
510(k) K013393
Identifiers
- 510(k) Number
- K013393 FDA 510(k)
- FDA Product Code
- KFM FDA 510(k)
- Models / Variants
- model #cp-1h FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4360 FDA 510(k)
- Regulation Number
- 870.4360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Heparin Coated Miniature Centrifugal Bypass Pump System +1 more model by A-Med Systems, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models
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 | K013393 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A-Med Systems, Inc.
Sources (1)
- FDA 510(k) K013393 24 fields · synced Jun 19, 2026