CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
FDA 510(k) clearance K953768 · decided 1995-11-22
Clearance details
- K-number
- K953768
- Device name
- CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
- Applicant
- Cordis Webster, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-14
- Decision date
- 1995-11-22
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- DRF
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Baldwin Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171- recall (Z-3037-2011) | Biosense Webster, Inc. | 2011-08-18 |
| Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog N recall (Z-3038-2011) | Biosense Webster, Inc. | 2011-08-18 |
| ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7 recall (Z-2664-2011) | Biosense Webster, Inc. | 2011-06-27 |
| HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT recall (Z-2665-2011) | Biosense Webster, Inc. | 2011-06-27 |