510(k) K031351
K031351 is an FDA 510(k) premarket notification submitted by Medigroup, Inc. for the device "FLEX-NECK PD CATHETER, INFANT". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code FJS (Catheter, Peritoneal, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Medigroup, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2003
- Date Received
- April 29, 2003
- 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