The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Titanium Powerport Isp Implanted Port With 6 Fr Chronoflex Polyurethane Catheter.
| Device ID | K072549 |
| 510k Number | K072549 |
| Device Name: | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
| Contact | Susan D Scott |
| Correspondent | Susan D Scott C.R. BARD, INC. 605 N 5600 W Salt Lake City, UT 84116 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-10 |
| Decision Date | 2007-11-14 |
| Summary: | summary |