The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Everst 30 Inflation Device/survival Kit.
| Device ID | K960983 |
| 510k Number | K960983 |
| Device Name: | MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT |
| Classification | Syringe, Balloon Inflation |
| Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Contact | Joseph O Magliozzi Rac |
| Correspondent | Joseph O Magliozzi Rac MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-11 |
| Decision Date | 1996-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169014817 | K960983 | 000 |
| 00643169014800 | K960983 | 000 |