The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerport Polymetric Port With 8 Fr S/l Chronoflex Catheter.
| Device ID | K063377 |
| 510k Number | K063377 |
| Device Name: | POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Michaela Rivkowich |
| Correspondent | Michaela Rivkowich C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2007-01-25 |
| Summary: | summary |