Recovery Filter System, Model RF-048F
FDA 510(k) K022236 · C.R. Bard, Inc.
510(k) numberK022236
Submission
- Device name
- Recovery Filter System, Model RF-048F
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- July 11, 2002
- Decision date
- November 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTK – Filter, Intravascular, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3375
- Specialty
- Cardiovascular
- Implant
- Yes
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Questions and answers
When was Recovery Filter System, Model RF-048F cleared by the FDA?
Recovery Filter System, Model RF-048F (K022236) received a 510(k) decision of Substantially Equivalent on November 27, 2002, 139 days after the submission was received.
What is the product code of K022236?
The FDA product code is DTK – Filter, Intravascular, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.3375.