The following data is part of a premarket notification filed by Clinipad Corp. with the FDA for V.a.d. Access Kit.
| Device ID | K932010 |
| 510k Number | K932010 |
| Device Name: | V.A.D. ACCESS KIT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
| Contact | Patricia Stawarz |
| Correspondent | Patricia Stawarz CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1994-02-03 |