510(k) K110491
K110491 is an FDA 510(k) premarket notification submitted by Pluromed, Inc. for the device "BACKSTOP CATHETER". The FDA issued a decision of Substantially Equivalent on Mar 16, 2011. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Pluromed, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 16, 2011
- Date Received
- Feb 22, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type