LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
FDA 510(k) clearance K023248 · decided 2003-02-11
Clearance details
- K-number
- K023248
- Device name
- LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
- Applicant
- Orbus Medical Technologies
- Decision
- Unknown
- Date received
- 2002-09-30
- Decision date
- 2003-02-11
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The product is a stainless steel stent mounted on a PTA balloon delivery device. The produ recall (Z-1075-04) | Orbus Medical Technologies Inc | 2004-07-20 |