DRAINAGE STENT
FDA 510(k) clearance K834468 · decided 1984-04-20
Clearance details
- K-number
- K834468
- Device name
- DRAINAGE STENT
- Applicant
- Microvasive
- Decision
- Substantially Equivalent
- Date received
- 1983-12-20
- Decision date
- 1984-04-20
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Milford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use on recall (Z-1102-04) | Boston Scientific Corp | 2004-07-20 |
| Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use o recall (Z-1103-04) | Boston Scientific Corp | 2004-07-20 |