POWERPICC
Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
BARD ACCESS SYSTEMS, INC.
The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Powerpicc.
Pre-market Notification Details
| Device ID | K053501 |
| 510k Number | K053501 |
| Device Name: | POWERPICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Lynn M Kirchoff |
| Correspondent | Lynn M Kirchoff BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
Trademark Results [POWERPICC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERPICC 78216794 2960842 Live/Registered |
C. R. Bard, Inc. 2003-02-20 |
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