K083675 is an FDA 510(k) clearance for the POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER. This device is classified as a Catheter, Hemodialysis, Triple Lumen, Non-implanted (Class II - Special Controls, product code NIE).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 19, 2009, 98 days after receiving the submission on December 11, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540. Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion..
| 510(k) Number | K083675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2008 |
| Decision Date | March 19, 2009 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NIE — Catheter, Hemodialysis, Triple Lumen, Non-implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Short-term (< 30 Days) Central Venous Access For Hemodialysis And Apheresis, With A Third Lumen For Infusion. |