Conquest Pta Balloon Dilatation Catheter
FDA 510(k) K083657 · C.R. Bard, Inc.
510(k) numberK083657
Submission
- Device name
- Conquest Pta Balloon Dilatation Catheter
- Applicant
- C.R. Bard, Inc.
Tempe, AZ, US - Received
- December 10, 2008
- Decision date
- December 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Conquest Pta Balloon Dilatation Catheter cleared by the FDA?
Conquest Pta Balloon Dilatation Catheter (K083657) received a 510(k) decision of Substantially Equivalent on December 24, 2008, 14 days after the submission was received.
What is the product code of K083657?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.