Cleared Special

K230934 - ViewFlex Eco Reprocessed ICE Catheter

K230934 is the FDA 510(k) clearance for ViewFlex Eco Reprocessed ICE Catheter by Abbott Medical. It is a Class 2 Cardiovascular device (product code OWQ) cleared through the Special 510(k) pathway after a 30-day FDA review.

K230934 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
30d
Days
Class 2
Risk

K230934 is an FDA 510(k) clearance for the ViewFlex™ Eco Reprocessed ICE Catheter. Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Abbott Medical (Minnetonka, US). The FDA issued a Cleared decision on May 3, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Abbott Medical devices

Submission Details

510(k) Number K230934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2023
Decision Date May 03, 2023
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.

Device Classification

Product Code OWQ Reprocessed Intravascular Ultrasound Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OWQ Reprocessed Intravascular Ultrasound Catheter

All 26
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K230934.
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
K231621 · Stryker Sustainability Solutions · Jul 2023
ViewFlex™ Eco Reprocessed ICE Catheter
K231588 · Abbott Medical · Jun 2023
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter
K230584 · Vein 360, LLC · Jun 2023
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K223026 · Northeast Scientific, Inc. · Feb 2023
ViewFlex Xtra Reprocessed ICE Catheter
K222217 · Abbott Medical · Dec 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · Innovative Health, LLC · May 2022