The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Soft-cell Dual Lumen Catheters.
| Device ID | K030277 |
| 510k Number | K030277 |
| Device Name: | SOFT-CELL DUAL LUMEN CATHETERS |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Glenn Norton |
| Correspondent | Glenn Norton 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-27 |
| Decision Date | 2003-08-06 |
| Summary: | summary |