Cleared Traditional

K864537 - 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

K864537 is an FDA 510(k) clearance for 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOO..., manufactured by Aries Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K864537 · Aries Medical, Inc. · Cardiovascular device
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Jun 1987
Decision
214d
Days
Class 2
Risk

K864537 is an FDA 510(k) clearance for the 40CC PERCUTANEOUS PRE-FURL (D/L) 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 June 19, 1987 after a review of 214 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

FDA 510(k) Submission Details - K864537

510(k) Number K864537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1986
Decision Date June 19, 1987
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSP Device Classification - Class 2, Special Controls

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 141
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K864537.
DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL
K880289 · Datascope Corp. · Jun 1988
INTRA-AORTIC BALLOON PUMP MODEL KAAT
K875036 · Kontron Instruments, Inc. · May 1988
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
K874816 · Kontron Instruments, Inc. · Apr 1988
40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER
K864994 · Aries Medical, Inc. · Jun 1987
40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER
K864567 · Aries Medical, Inc. · May 1987
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER
K864568 · Aries Medical, Inc. · May 1987