Submission Details
| 510(k) Number | K141531 FDA.gov |
| FDA Decision | Cleared SEKD |
| Date Received | June 09, 2014 |
| Decision Date | June 01, 2015 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
Jun 2015
Decision
357d
Days
Class 2
Risk
About This 510(k) Submission
K141531 is an FDA 510(k) clearance for the POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER, 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 June 1, 2015, 357 days after receiving the submission on June 9, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
Device Classification
| 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. |
Manufacturer
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