RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
FDA 510(k) clearance K140523 · decided 2014-07-24
Clearance details
- K-number
- K140523
- Device name
- RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 2014-03-04
- Decision date
- 2014-07-24
- Days to decision
- 142 days
- Clearance type
- Special
- Product code
- FED
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.