The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Cathlink 20 Titanium Port W/att. Polyurethane Cath.
| Device ID | K926139 |
| 510k Number | K926139 |
| Device Name: | CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Jane Ann Martin |
| Correspondent | Jane Ann Martin BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART 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 | 1992-12-07 |
| Decision Date | 1995-01-03 |