DESTINATION CAROTID GUIDING SHEATH
FDA 510(k) clearance K052185 · decided 2005-09-06
Clearance details
- K-number
- K052185
- Device name
- DESTINATION CAROTID GUIDING SHEATH
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-11
- Decision date
- 2005-09-06
- Days to decision
- 26 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 Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot recall (Z-2416-2011) | Terumo Medical Corporation | 2011-06-06 |