Cleared Traditional

K895511 - CATHETER BALLOON DILATOR PRESSURE GAUGE

K895511 is the FDA 510(k) clearance for CATHETER BALLOON DILATOR PRESSURE GAUGE by Argon Medical Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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
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.

Device Classification

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 30
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K895511.
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 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