K053589 is an FDA 510(k) clearance for the LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Bard Access Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 13, 2006, 111 days after receiving the submission on December 23, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K053589 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2005 |
| Decision Date | April 13, 2006 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSD — Catheter, Hemodialysis, Implanted |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5540 |