The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Interventional Vascular Y-adapter, Tri-adapter, Tri-adapter & Accessory Packs.
| Device ID | K940063 |
| 510k Number | K940063 |
| Device Name: | MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Timothy J Johnson |
| Correspondent | Timothy J Johnson 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 | 1994-01-06 |
| Decision Date | 1994-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169002955 | K940063 | 000 |
| 20643169002948 | K940063 | 000 |
| 20643169002931 | K940063 | 000 |
| 20643169843091 | K940063 | 000 |
| 20643169843084 | K940063 | 000 |
| 20643169843077 | K940063 | 000 |
| 00681490225748 | K940063 | 000 |