Cleared Traditional

K896849 - ACS INDEFLATOR XX

K896849 is the FDA 510(k) clearance for ACS INDEFLATOR XX by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code MAV) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K896849 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Feb 1990
Decision
85d
Days
Class 2
Risk

K896849 is an FDA 510(k) clearance for the ACS INDEFLATOR XX. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Temecula, US). The FDA issued a Cleared decision on February 28, 1990 after a review of 85 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 K896849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date February 28, 1990
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAV Syringe, Balloon Inflation
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 - MAV Syringe, Balloon Inflation

All 29
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K896849.
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 1991
DISPOSABLE INFLATION GAUGE
K902695 · Cook Urological, Inc. · Dec 1990
INFLATION/DEFLATION DEVICE
K904394 · Boston Scientific Corp · Dec 1990
INFLATION PRO II
K895836 · Baxter Healthcare Corp · Dec 1989
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · Shiley, Inc. · Jun 1986
SCIMED PM200 INFLATION MANOMETER
K843448 · Scimed Life Systems, Inc. · Oct 1984