Cleared Special

AC3 Series Intra-Aortic Balloon Pump (IABP) (K192238) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192238 · Arrow International, Teleflex · Cardiovascular device
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Nov 2019
Decision
85d
Days
Class 2
Risk

K192238 is an FDA 510(k) clearance for the AC3 Series Intra-Aortic Balloon Pump (IABP). Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Arrow International, Teleflex (Chelmsford, US). The FDA issued a Cleared decision on November 12, 2019 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arrow International, Teleflex devices

Submission Details

510(k) Number K192238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2019
Decision Date November 12, 2019
Days to Decision 85 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
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
Modification to existing cleared device.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 161
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K192238.
AC3™ Range™ Intra-Aortic Balloon Pump
K250542 · Arrow International, LLC · Mar 2025
AC3™ Series IABP
K232343 · Arrow International, LLC · Aug 2023
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · Arrow International, Inc. · May 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · Arrow International, Inc. · Apr 2020
UltraFlex IAB
K190101 · Arrow International, Inc. · Jun 2019
Fiberoptix IAB
K190117 · Arrow International, Inc. · Jun 2019