PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
FDA 510(k) clearance K091329 · decided 2009-05-29
Clearance details
- K-number
- K091329
- Device name
- PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-05
- Decision date
- 2009-05-29
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Va recall (Z-1611-2013) | Terumo Medical Corporation | 2013-06-27 |