Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit

Syringe, Balloon Inflation

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit.

Pre-market Notification Details

• Device ID: K153038
• 510k Number: K153038
• Device Name: Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
• Classification: Syringe, Balloon Inflation
• Applicant: MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers, MA 01923
• Contact: Nisarg Shah
• Correspondent: Nisarg Shah; MEDTRONIC, INC. 37A CHERRY HILL DRIVE Danvers, MA 01923
• Product Code: MAV
• CFR Regulation Number: 870.1650 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-19
• Decision Date: 2016-04-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169843042	K153038	000
00643169843035	K153038	000
00643169843028	K153038	000
00643169843011	K153038	000
00643169621923	K153038	000
00643169621916	K153038	000
00643169621909	K153038	000
00643169621893	K153038	000