The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerhohn And Powerline Catheters.
| Device ID | K050185 |
| 510k Number | K050185 |
| Device Name: | POWERHOHN AND POWERLINE CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Chrles Morreale |
| Correspondent | Chrles Morreale C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-27 |
| Decision Date | 2005-05-26 |
| Summary: | summary |