MEDTRONIC EVEREST INFLATION DEVICE— 510(k) K942269

Clearance details

Applicant

Medtronics Interventional Vascular

Product code

Code MAV

Device class

Class 2

Regulation

21 CFR 870.1650

Advisory panel

Cardiovascular

Date received

1994-05-10

Decision date

1994-10-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Danvers, MA, US

• K260035 — Digital Indeflator INFLANTE2026-09-04
• K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more2022-04-13
• K162272 — Fluent inflation device2016-10-20
• K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit2016-04-13
• K153672 — basixTOUCH40 Inflation Syringe2016-01-20

• K990707 — MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS1999-03-22
• K980973 — MEDTRONIC ANGIOGRAPHIC CATHETER1998-12-10
• K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER1998-09-04
• K981198 — MEDTRONIC ZUMA GUIDING CATHETER1998-08-07
• K972944 — MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT1997-11-03

Malfunction

1,433

Total

1,433

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1121-2014 — Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.Class III·Terminated·Medtronic Vascular·20140206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K942269.