Submission Details
| 510(k) Number | K101261 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 2010 |
| Decision Date | July 29, 2010 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
Jul 2010
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K101261 is an FDA 510(k) clearance for the CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000, a Kit, Repair, Catheter, Hemodialysis (Class II — Special Controls, product code NFK), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on July 29, 2010, 85 days after receiving the submission on May 5, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
Device Classification
| Product Code | NFK — Kit, Repair, Catheter, Hemodialysis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |
| Definition | Hemodialysis Tray |
Manufacturer
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