VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
FDA 510(k) clearance K981591 · decided 1998-10-09
Clearance details
- K-number
- K981591
- Device name
- VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
- Applicant
- International Regulatory Consultants
- Decision
- Substantially Equivalent
- Date received
- 1998-05-04
- Decision date
- 1998-10-09
- Days to decision
- 158 days
- Clearance type
- Special
- Product code
- FAD
- Device class
- 2
- Regulation number
- 876.4620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.