Cleared Special

K231621 - Reprocessed ViewFlex Xtra ICE Catheter (D087031)

K231621 is an FDA 510(k) clearance for Reprocessed ViewFlex Xtra ICE Catheter ..., manufactured by Stryker Sustainability Solutions. The device is a Class 2 Cardiovascular device with product code OWQ cleared through the Special 510(k) pathway after a 53-day FDA review.

K231621 · Stryker Sustainability Solutions · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
53d
Days
Class 2
Risk

K231621 is an FDA 510(k) clearance for the Reprocessed ViewFlex Xtra ICE Catheter (D087031). Classified as Reprocessed Intravascular Ultrasound Catheter (product code OWQ), Class II - Special Controls.

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on July 25, 2023 after a review of 53 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.

FDA 510(k) Submission Details - K231621

510(k) Number K231621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date July 25, 2023
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

OWQ Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (OWQ) and FDA review panel - the closest regulatory comparables to K231621.
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
K232130 · Surgical Instrument Services and Savings, Inc. · Dec 2023
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
K232584 · Vein 360, LLC · Oct 2023
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
K230928 · Vein 360, LLC · Aug 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
ViewFlex™ Eco Reprocessed ICE Catheter
K230934 · Abbott Medical · May 2023
K231621 · Reprocessed ViewFlex Xtra ICE Catheter (D087031)
Download PDF FDA Summary Stryker Sustainabilit…