INTRASTENT LD (LARGE DIAMETER) STENT
FDA 510(k) clearance K020528 · decided 2002-04-16
Clearance details
- K-number
- K020528
- Device name
- INTRASTENT LD (LARGE DIAMETER) STENT
- Applicant
- Sulzer Intratherapeutics, Inc.
- Decision
- Unknown
- Date received
- 2002-02-19
- Decision date
- 2002-04-16
- Days to decision
- 56 days
- Clearance type
- Special
- 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
No recalls on record reference this clearance.