The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Catheter Repair Kit With Replacement Connector, Model 5587000.
| Device ID | K011015 |
| 510k Number | K011015 |
| Device Name: | CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
| Classification | Kit, Repair, Catheter, Hemodialysis |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Peggy Keiffer |
| Correspondent | Peggy Keiffer C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | NFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-06-22 |