Modification to Angiodynamics Profiler Pta Balloon Catheter
FDA 510(k) K062609 · AngioDynamics, Inc.
510(k) numberK062609
Submission
- Device name
- Modification to Angiodynamics Profiler Pta Balloon Catheter
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- September 5, 2006
- Decision date
- October 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 Modification to Angiodynamics Profiler Pta Balloon Catheter cleared by the FDA?
Modification to Angiodynamics Profiler Pta Balloon Catheter (K062609) received a 510(k) decision of Substantially Equivalent on October 6, 2006, 31 days after the submission was received.
What is the product code of K062609?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.