Medtronic Model 6550 Adjustable Hemostasis Valve
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K874117 FDA 510(k)
- FDA Product Code
- DYG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1240 FDA 510(k)
- Regulation Number
- 870.1240 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 6550 Adjustable Hemostasis Valve is a Catheter, Flow Directed designed to control and regulate blood flow within vascular procedures. It incorporates an adjustable mechanism to maintain hemostasis, ensuring precise control during interventions such as angiography or catheterization.
This device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings. It is classified under FDA regulation 870.1240 and holds an FDA 510K clearance (K874117) for cardiovascular applications. The valve is engineered for compatibility with standard vascular procedures and adheres to Class II special controls.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medtronic Model 6550 Adjustable Hemostasis Valve… - FDA.report, Medtronic Model 6550 Adjustable Hemostasis Valve, K874117 FDA 510(k) - MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTA...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K874117 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K874117 24 fields · synced Oct 6, 2026