CONSTELLATION CATHETERS, MODEL 8031M
FDA 510(k) clearance K021232 · decided 2002-05-16
Clearance details
- K-number
- K021232
- Device name
- CONSTELLATION CATHETERS, MODEL 8031M
- Applicant
- Boston Scientific Corp
- Decision
- Unknown
- Date received
- 2002-04-18
- Decision date
- 2002-05-16
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MTD
- Device class
- 2
- Regulation number
- 870.1220
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075 recall (Z-0639-05) | Boston Scientific | 2005-03-18 |