Cleared Traditional

K895433 - ARIES 30CC & 50CC INTRA-AORTIC BALLOON ...

K895433 is the FDA 510(k) clearance for ARIES 30CC & 50CC INTRA-AORTIC BALLOON ... by Aries Medical, Inc.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K895433 · Aries Medical, Inc. · Cardiovascular device
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Apr 1990
Decision
215d
Days
Class 2
Risk

K895433 is an FDA 510(k) clearance for the ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS. 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 April 10, 1990 after a review of 215 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 K895433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1989
Decision Date April 10, 1990
Days to Decision 215 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 125d · This submission: 215d
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 K895433.
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
K902057 · Datascope Corp. · Sep 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · Datascope Corp. · Aug 1990
SERIES 3001 IABP
K900281 · Boston Scientific Corp · Apr 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920 · Boston Scientific Corp · Mar 1990
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
K896597 · Boston Scientific Corp · Feb 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430 · Datascope Corp. · Feb 1990