Cleared Traditional

K911295 - ANGIOPLASTY INFLATOR

K911295 is an FDA 510(k) clearance for ANGIOPLASTY INFLATOR, manufactured by Vastek. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K911295 · Vastek · Cardiovascular device
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Jul 1991
Decision
109d
Days
Class 2
Risk

K911295 is an FDA 510(k) clearance for the ANGIOPLASTY INFLATOR. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Vastek (Dayton, US). The FDA issued a Cleared decision on July 12, 1991 after a review of 109 days - within the typical 510(k) review window.

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 Vastek devices

FDA 510(k) Submission Details - K911295

510(k) Number K911295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date July 12, 1991
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
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 50
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K911295.
MONARCH(TM) INFLATION SYRINGE
K913994 · Merit Medical Systems, Inc. · Feb 1992
CORDIS INFLATOR DEVICE
K912644 · Cordis Corp. · Sep 1991
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 1991
BIPOLAR FORCEPS
K912544 · Everest Medical Corp. · Jun 1991
CONDOR ANALOG INFLATION SYRINGE
K904508 · Professional Medical Services · Apr 1991
CONDOR DIGITAL INFLATION SYRINGE
K904954 · Professional Medical Services · Jan 1991