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PRONTO V4 EXTRACTION CATHETER 5.5F - Pronto V4 Extraction Cath
FDA 510(k)Class II (US FDA 510(k))
510(k) K103405
Identifiers
- 510(k) Number
- K103405 FDA 510(k)
- FDA Product Code
- QEZ FDA 510(k)
- Models / Variants
- Pronto V4 Extraction Catheter 5.5f FDA 510(k)Pronto V4 Extraction Catheter 6f FDA 510(k)Pronto V4 Extraction 7f FDA 510(k)Pronto V4 Extraction Cath FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
PRONTO V4 EXTRACTION CATHETER 5.5F - Pronto V4 Extraction Cath by Vascular Solutions, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K103405 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA 510(k) K103405 24 fields · synced Jun 18, 2026