MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
FDA 510(k) clearance K062609 · decided 2006-10-06
Clearance details
- K-number
- K062609
- Device name
- MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-09-05
- Decision date
- 2006-10-06
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAM recall (Z-3261-2011) | Angiodynamics Worldwide Headquarters | 2011-09-19 |
| ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801105, BALLOON DIAM recall (Z-3262-2011) | Angiodynamics Worldwide Headquarters | 2011-09-19 |