The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Optiflow Catheter #5641190 Catheter Only #5643150 Catheter Kit #5631000 Catheterless Tray-generic (combined With Cathetr.
| Device ID | K010567 |
| 510k Number | K010567 |
| Device Name: | OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR |
| Classification | Catheter, Hemodialysis, Implanted |
| 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 | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-03-28 |