Advance 14RX Rapid Exchange Pta Balloon Catheter
FDA 510(k) K090822 · Cook, Inc.
510(k) numberK090822
Submission
- Device name
- Advance 14RX Rapid Exchange Pta Balloon Catheter
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- March 26, 2009
- Decision date
- April 27, 2009
- 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 Advance 14RX Rapid Exchange Pta Balloon Catheter cleared by the FDA?
Advance 14RX Rapid Exchange Pta Balloon Catheter (K090822) received a 510(k) decision of Substantially Equivalent on April 27, 2009, 32 days after the submission was received.
What is the product code of K090822?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.