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Panels › Cardiovascular › Product code OWQ · Class 2

Reprocessed Intravascular Ultrasound Catheter

Regulation 870.1200

1510(k)s in 12 months (31 all time)
5recalls in 12 months (10 all time)
9recalls that name a 510(k)
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Top companies in OWQ

DateFirm and productCodeLinked 510(k)
Feb 6, 2026Medline Industries, LP
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Syste
Open, Classified
OWQK234064
Feb 6, 2026Medline Industries, LP
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco
Open, Classified
OWQK250545
Feb 6, 2026Medline Industries, LP
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554
Open, Classified
OWQK232130
Nov 20, 2025Sterilmed, Inc.
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A P
Open, Classified
OWQK043453
Nov 20, 2025Sterilmed, Inc.
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Numb
Open, Classified
OWQK043453
Sep 26, 2025Medline Industries, LP
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart
Open, Classified
OWQK234064
Sep 26, 2025Medline Industries, LP
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Open, Classified
OWQK232130
Apr 26, 2021Northeast Scientific Inc.
NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such ves
Terminated
OWQNone listed
Jun 1, 2020Stryker Sustainability Solutions
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
Terminated
OWQK182238
Oct 9, 2014STERILMED, INC.
Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Terminated
OWQK110076

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