Cleared Traditional

K942269 - MEDTRONIC EVEREST INFLATION DEVICE

K942269 is an FDA 510(k) clearance for MEDTRONIC EVEREST INFLATION DEVICE, manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K942269 · Medtronics Interventional Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
161d
Days
Class 2
Risk

K942269 is an FDA 510(k) clearance for the MEDTRONIC EVEREST INFLATION DEVICE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K942269

510(k) Number K942269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1994
Decision Date October 18, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MAV Syringe, Balloon Inflation

All 38
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K942269.
SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICE
K955869 · Scimed Life Systems, Inc. · Mar 1996
OSCILFLATOR
K952566 · Surgical Technologies, Inc. · Aug 1995
MONARCH AP(TM)
K943597 · Merit Medical Systems, Inc. · Feb 1995
MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE
K940896 · Medex, Inc. · Aug 1994
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
K940425 · Imagyn Medical, Inc. · Aug 1994
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · Boston Scientific Corp · Dec 1992