Cleared Special

K200634 - Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

K200634 is an FDA 510(k) clearance for Arrow FiberOptix Intra-Aortic Balloon C..., manufactured by Arrow International, Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Special 510(k) pathway after a 30-day FDA review.

K200634 · Arrow International, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
30d
Days
Class 2
Risk

K200634 is an FDA 510(k) clearance for the Arrow FiberOptix Intra-Aortic Balloon Catheter Kit. 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 April 9, 2020 after a review of 30 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.

FDA 510(k) Submission Details - K200634

510(k) Number K200634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2020
Decision Date April 09, 2020
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DSP Device Classification - Class 2, Special Controls

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 156
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K200634.
AC3™ Range™ Intra-Aortic Balloon Pump
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K232343 · Arrow International, LLC · Aug 2023
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K201112 · Arrow International, Inc. · May 2020
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · Arrow International, Teleflex · Nov 2019
UltraFlex IAB
K190101 · Arrow International, Inc. · Jun 2019
Fiberoptix IAB
K190117 · Arrow International, Inc. · Jun 2019
K200634 · Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
Download PDF FDA Summary Arrow International, …