510(k) K071496
K071496 is an FDA 510(k) premarket notification submitted by Colorado Catheter Company, Inc. for the device "ICATH, STERILESURE". The FDA issued a decision of Substantially Equivalent (kit) on August 15, 2007. The device falls under product code NWO (Kit, Catheter, Urinary (Exludes Hiv Testing)), a Class II device regulated under 21 CFR 876.5130.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- August 15, 2007
- Date Received
- May 31, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Kit, Catheter, Urinary (Exludes Hiv Testing)
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
Urinary Catheterization Kit (Excludes HIV Testing)