PRIMUS GPS BILIARY STENT SYSTEM
FDA 510(k) clearance K061566 · decided 2006-08-31
Clearance details
- K-number
- K061566
- Device name
- PRIMUS GPS BILIARY STENT SYSTEM
- Applicant
- Ev3, Inc.
- Decision
- Unknown
- Date received
- 2006-06-06
- Decision date
- 2006-08-31
- Days to decision
- 86 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ev3
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.