510(k) K113354
K113354 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "VETA PERITONEAL DIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent (kit) on March 13, 2012. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 13, 2012
- Date Received
- November 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peritoneal, Long-Term Indwelling
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type