The following data is part of a premarket notification filed by Bard Access Systems, Inc. with the FDA for Plastic Low Profile Subcutaneous Port.
| Device ID | K924250 |
| 510k Number | K924250 |
| Device Name: | PLASTIC LOW PROFILE SUBCUTANEOUS PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | BARD ACCESS SYSTEMS, INC. 5425 WEST AMELIA EARNHART DR. Salt Lake City, UT 84116 |
| Contact | Jack Speer |
| Correspondent | Jack Speer 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 | 1992-08-24 |
| Decision Date | 1993-10-04 |