The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Acessory Pack.
| Device ID | K923638 |
| 510k Number | K923638 |
| Device Name: | ACESSORY PACK |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Kirk Daly |
| Correspondent | Kirk Daly MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1993-02-08 |