Cleared Traditional

CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY (K863537) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863537 · Cordis Corp. · Cardiovascular device
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Oct 1986
Decision
50d
Days
Class 2
Risk

K863537 is an FDA 510(k) clearance for the CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on October 31, 1986 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cordis Corp. devices

Submission Details

510(k) Number K863537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1986
Decision Date October 31, 1986
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
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 - DXT Injector And Syringe, Angiographic

All 50
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K863537.
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · Merit Medical Systems, Inc. · Apr 1989
ANGIO DRAPE PACK ACP-010FM
K880310 · Arrow Intl., Inc. · Apr 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · C.R. Bard, Inc. · Sep 1986
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · Cordis Corp. · Jan 1984
USCI BALLOON DILATATION INFLATION DEV.
K791782 · C.R. Bard, Inc. · Dec 1979