Cleared Traditional

K872981 - ACS INDEFLATOR PLUS (MODIFICATION #2)

K872981 is the FDA 510(k) clearance for ACS INDEFLATOR PLUS (MODIFICATION #2) by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K872981 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Oct 1987
Decision
81d
Days
Class 2
Risk

K872981 is an FDA 510(k) clearance for the ACS INDEFLATOR PLUS (MODIFICATION #2). Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Temecula, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 81 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K872981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1987
Decision Date October 20, 1987
Days to Decision 81 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
44d faster than avg
Panel avg: 125d · This submission: 81d
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 K872981.
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DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988
MEDRAD MRI INJECTION SYSTEM
K873173 · Medrad, Inc. · Feb 1988
CAVROPUMP
K871129 · Life-Tech Intl., Inc. · Aug 1987
CHIN-FOGARTY INFLATION DEVICE
K863596 · American Edwards Laboratories · Nov 1986
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537 · Cordis Corp. · Oct 1986