Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter
FDA 510(k) K012913 · C.R. Bard, Inc.
510(k) numberK012913
Submission
- Device name
- Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- August 30, 2001
- Decision date
- September 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter cleared by the FDA?
Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter (K012913) received a 510(k) decision of Substantially Equivalent on September 28, 2001, 29 days after the submission was received.
What is the product code of K012913?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.