BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
FDA 510(k) clearance K033441 · decided 2003-11-21
Clearance details
- K-number
- K033441
- Device name
- BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2003-10-29
- Decision date
- 2003-11-21
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- 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, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664. recall (Z-1164-2014) | Boston Scientific Corporation | 2014-03-10 |
| RunWay 6F Cardiovascular Guide Catheter. recall (Z-0454-05) | Boston Scientific Scimed | 2005-01-28 |