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)
Top companies in OWQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2026 | Medline 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 |
OWQ | K234064 |
| Feb 6, 2026 | Medline 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 |
OWQ | K250545 |
| Feb 6, 2026 | Medline Industries, LP Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:
ViewFlex Xtra ICE Catheter 9F x 90cm
D087031RH
20197344019554 Open, Classified |
OWQ | K232130 |
| Nov 20, 2025 | Sterilmed, 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 |
OWQ | K043453 |
| Nov 20, 2025 | Sterilmed, 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 |
OWQ | K043453 |
| Sep 26, 2025 | Medline 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 |
OWQ | K234064 |
| Sep 26, 2025 | Medline 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 |
OWQ | K232130 |
| Apr 26, 2021 | Northeast 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 |
OWQ | None listed |
| Jun 1, 2020 | Stryker 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 |
OWQ | K182238 |
| Oct 9, 2014 | STERILMED, INC. Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577. Terminated |
OWQ | K110076 |
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