CONVOY ADVANCED DELIVERY SHEATH
FDA 510(k) clearance K072719 · decided 2008-03-07
Clearance details
- K-number
- K072719
- Device name
- CONVOY ADVANCED DELIVERY SHEATH
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2007-09-25
- Decision date
- 2008-03-07
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- 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 |
|---|---|---|
| Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, recall (Z-1072-2009) | Boston Scientific Corp | 2009-04-09 |