Cleared Traditional

Fiberoptix IAB (K190117) - FDA 510(k) Clearance

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

K190117 · Arrow International, Inc. · Cardiovascular device
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Jun 2019
Decision
140d
Days
Class 2
Risk

K190117 is an FDA 510(k) clearance for the Fiberoptix IAB. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Arrow International, Inc. (Chelmsford, US). The FDA issued a Cleared decision on June 13, 2019 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Arrow International, Inc. devices

Submission Details

510(k) Number K190117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2019
Decision Date June 13, 2019
Days to Decision 140 days
Submission Type Traditional
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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K190117.
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
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · Arrow International, Teleflex · Nov 2019
UltraFlex IAB
K190101 · Arrow International, Inc. · Jun 2019