BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
FDA 510(k) clearance K022621 · decided 2002-09-04
Clearance details
- K-number
- K022621
- Device name
- BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2002-08-07
- Decision date
- 2002-09-04
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Ma recall (Z-1394-2012) | Boston Scientific Corporation | 2012-04-11 |