MEDTRONIC EVEREST INFLATION DEVICE

Syringe, Balloon Inflation

MEDTRONICS INTERVENTIONAL VASCULAR

The following data is part of a premarket notification filed by Medtronics Interventional Vascular with the FDA for Medtronic Everest Inflation Device.

Pre-market Notification Details

• Device ID: K942269
• 510k Number: K942269
• Device Name: MEDTRONIC EVEREST INFLATION DEVICE
• Classification: Syringe, Balloon Inflation
• Applicant: MEDTRONICS INTERVENTIONAL VASCULAR 37A CHERRY HILL DR. Danvers, MA 01923
• Contact: Joseph O Magliozzi
• Correspondent: Joseph O Magliozzi; 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: 1994-05-10
• Decision Date: 1994-10-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169014794	K942269	000
00643169014787	K942269	000