ICATH, STERILESURE
FDA 510(k) clearance K071496 · decided 2007-08-15
Clearance details
- K-number
- K071496
- Device name
- ICATH, STERILESURE
- Applicant
- Colorado Catheter Company, Inc.
- Decision
- Unknown
- Date received
- 2007-05-31
- Decision date
- 2007-08-15
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- NWO
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Colorado Springs, CO, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.