GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
FDA 510(k) clearance K991032 · decided 1999-04-30
Clearance details
- K-number
- K991032
- Device name
- GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
- Applicant
- Guidant Corp.
- Decision
- Unknown
- Date received
- 1999-03-29
- Decision date
- 1999-04-30
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- 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
No recalls on record reference this clearance.