Recovery Filter System, Model RF-210F
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050558 FDA 510(k)
- FDA Product Code
- DTK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3375 FDA 510(k)
- Regulation Number
- 870.3375 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The Recovery Filter System, Model Rf-210f is an intravascular, cardiovascular filter. It is classified as a Filter, Intravascular, Cardiovascular device. The device is used in cardiovascular applications.
The Recovery Filter System, Model Rf-210f is supplied with a product code of DTK and is classified as a Class II device with special controls. It was cleared by the FDA on August 29, 2005, with the clearance number K050558. The device is used in a medical setting and is intended for single use.
Frequently asked questions
What is the Recovery Filter System used for?
The Recovery Filter System, Model RF-210F, is used in cardiovascular applications, specifically as an intravascular filter.
Is the Recovery Filter System supplied sterile?
The description does not explicitly state that the device is supplied sterile, but it is intended for single use in a medical setting.
What is the regulatory classification of the Recovery Filter System?
The Recovery Filter System, Model RF-210F, is classified as a Class II device with special controls, and was cleared by the FDA with the clearance number K050558.
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: Modification To: Recovery Filter System, Model Rf-210f, MODIFICATION TO: RECOVERY FILTER SYSTE... (K050558) - FDA 510(k), www.accessdata.fda.gov, K031328 FDA 510(k) - RECOVERY FILTER SYSTEM | C.R. Bard, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050558 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K050558 24 fields · synced Sep 27, 2026