GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
FDA 510(k) clearance K030512 · decided 2003-05-14
Clearance details
- K-number
- K030512
- Device name
- GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-19
- Decision date
- 2003-05-14
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Numbe recall (Z-0614-2011) | CTS, Inc. dba Guidant Cardiac Surgery | 2010-12-13 |