The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Power-injectable Implantable Ports With Chronoflex Polyurethane Catheters.
| Device ID | K150514 |
| 510k Number | K150514 |
| Device Name: | Power-Injectable Implantable Ports With ChronoFlex Polyurethane Catheters |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. Bard, Inc. Salt Lake City, UT 84116 |
| Contact | James R. Davis |
| Correspondent | James R. Davis C.R. Bard, Inc. Bard Access Systems, Inc. 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 | 2015-02-27 |
| Decision Date | 2015-11-20 |
| Summary: | summary |