The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Long-term Hemodialysis Catheters With Biobloc Coating.
| Device ID | K053589 |
| 510k Number | K053589 |
| Device Name: | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-04-13 |
| Summary: | summary |