Cleared Traditional

K864567 - 40CC PERCUTANEOUS FURL DOU. LUMEN BALLO...

K864567 is the FDA 510(k) clearance for 40CC PERCUTANEOUS FURL DOU. LUMEN BALLO... by Aries Medical, Inc.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K864567 · Aries Medical, Inc. · Cardiovascular device
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May 1987
Decision
174d
Days
Class 2
Risk

K864567 is an FDA 510(k) clearance for the 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on May 12, 1987 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 Aries Medical, Inc. devices

Submission Details

510(k) Number K864567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date May 12, 1987
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 107
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K864567.
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942 · Boston Scientific Corp · Sep 1989
INTRA AORTIC BALLOON
K893243 · Datascope Corp. · Jun 1989
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289 · Datascope Corp. · Jun 1988
SYSTEM 90 TRANSPORT
K863219 · Datascope Corp. · Jan 1987
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985