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COOL LINE CATHETER - Model Ic-4593
FDA 510(k)Class II (US FDA 510(k))
510(k) K101987
Identifiers
- 510(k) Number
- K101987 FDA 510(k)
- FDA Product Code
- NCX FDA 510(k)
- Models / Variants
- Cl-2295a FDA 510(k)Icy Catheter FDA 510(k)Model Ic-3893a FDA 510(k)Quattro Catheter FDA 510(k)Model Ic-4593 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5900 FDA 510(k)
- Regulation Number
- 870.5900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
COOL LINE CATHETER - Model Ic-4593 by Zoll Circulation — Class II — FDA_510K — listed in FDA 510(k) — 5 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 | K101987 | Class II | Active |
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Manufacturer
- Manufacturer
- Zoll Circulation
Sources (1)
- FDA 510(k) K101987 24 fields · synced Jun 19, 2026