510(k) K150550
K150550 is an FDA 510(k) premarket notification submitted by Covalontechnologies, Inc. for the device "SilverCoat Silicone Foley Catheter". The FDA issued a decision of Substantially Equivalent on November 24, 2015. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Covalontechnologies, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 2015
- Date Received
- March 3, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type