Cleared Traditional

K895511 - CATHETER BALLOON DILATOR PRESSURE GAUGE

K895511 is an FDA 510(k) clearance for CATHETER BALLOON DILATOR PRESSURE GAUGE, manufactured by Argon Medical Corp.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K895511 · Argon Medical Corp. · Cardiovascular device
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Feb 1990
Decision
169d
Days
Class 2
Risk

K895511 is an FDA 510(k) clearance for the CATHETER BALLOON DILATOR PRESSURE GAUGE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Argon Medical Corp. (Athens, US). The FDA issued a Cleared decision on February 28, 1990 after a review of 169 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 Argon Medical Corp. devices

FDA 510(k) Submission Details - K895511

510(k) Number K895511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date February 28, 1990
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 46
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K895511.
MORSE BALLOON INFLATION DEVICE
K904275 · North American Instrument Corp. · Jan 1991
DISPOSABLE INFLATION GAUGE
K902695 · Cook Urological, Inc. · Dec 1990
INFLATION/DEFLATION DEVICE
K904394 · Boston Scientific Corp · Dec 1990
ACS INDEFLATOR XX
K896849 · Advanced Cardiovascular Systems, Inc. · Feb 1990
INFLATION PRO II
K895836 · Baxter Healthcare Corp · Dec 1989
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · Shiley, Inc. · Jun 1986