INTRASTENT DOUBLESTRUT LD
FDA 510(k) clearance K993904 · decided 2000-02-01
Clearance details
- K-number
- K993904
- Device name
- INTRASTENT DOUBLESTRUT LD
- Applicant
- Intratherapeutics, Inc.
- Decision
- Unknown
- Date received
- 1999-11-17
- Decision date
- 2000-02-01
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nath recall (Z-0829-06) | Ev3, Inc | 2006-05-03 |