510(k) K051711
K051711 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS". The FDA issued a decision of Substantially Equivalent on Nov 15, 2005. The device falls under product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Denver Biomedical, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 15, 2005
- Date Received
- Jun 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type
- 510(k)
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.