Cleared Traditional

K863596 - CHIN-FOGARTY INFLATION DEVICE

K863596 is the FDA 510(k) clearance for CHIN-FOGARTY INFLATION DEVICE by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K863596 · American Edwards Laboratories · Cardiovascular device
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Nov 1986
Decision
66d
Days
Class 2
Risk

K863596 is an FDA 510(k) clearance for the CHIN-FOGARTY INFLATION DEVICE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 66 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 American Edwards Laboratories devices

Submission Details

510(k) Number K863596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1986
Decision Date November 20, 1986
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K863596.
MEDRAD MRI INJECTION SYSTEM
K873173 · Medrad, Inc. · Feb 1988
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · Advanced Cardiovascular Systems, Inc. · Oct 1987
CAVROPUMP
K871129 · Life-Tech Intl., Inc. · Aug 1987
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537 · Cordis Corp. · Oct 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · C.R. Bard, Inc. · Sep 1986
MECHANICAL INFLATION DEVICE
K862547 · American Edwards Laboratories · Sep 1986