Cleared Traditional

K882289 - ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.

K882289 is an FDA 510(k) clearance for ARIES 40CC PERCU. (D/L) INTRA-AORTIC BA..., manufactured by Aries Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K882289 · Aries Medical, Inc. · Cardiovascular device
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Dec 1988
Decision
194d
Days
Class 2
Risk

K882289 is an FDA 510(k) clearance for the ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Aries Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on December 12, 1988 after a review of 194 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 - K882289

510(k) Number K882289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1988
Decision Date December 12, 1988
Days to Decision 194 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
69d slower than avg
Panel avg: 125d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 138
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K882289.
VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION)
K894732 · Medtronic Vascular · Oct 1989
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE)
K893459 · Medtronic Vascular · Sep 1989
TORAY VASCULAR PROSTHESIS
K884083 · Toray Industries (America), Inc. · Jan 1989
MEADOX INTRA-AORTIC GRAFT
K881283 · Meadox Medicals, Div. Boston Scientific Corp. · May 1988
GORE-TEX VASCULAR GRAFT
K880167 · W.L. Gore & Associates, Inc. · May 1988
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · Edward Weck, Inc. · Aug 1987