Atlas FDA

OWQ

31 FDA 510(k) clearances · Product code

147 daysmedian time to decision
263 days90th percentile
31clearances measured

FDA profile

Official device name
Reprocessed Intravascular Ultrasound Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1200
Medical specialty
Cardiovascular
FDA definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Adverse events (MAUDE)
2021: 38 · 2022: 24 · 2023: 28 · 2024: 37 · 2025: 42 · 2026: 38
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) (K254149)Sterilmed, Inc.2026-06-29
Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (K250545)Surgical Instrument Service and Savings, Inc.2025-06-05
NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (K250592)Northeast Scientific, Inc.2025-05-12
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) (K243101)Surgical Instrument Service and Savings, Inc.2025-03-10
Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) (K234064)Surgical Instrument Service and Savings, Inc.2024-09-10
Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter (K232130)Surgical Instrument Services and Savings, Inc.2023-12-15
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, LLC2023-10-24
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (K230928)Vein 360, LLC2023-08-25
Reprocessed ViewFlex Xtra ICE Catheter (D087031) (K231621)Stryker Sustainability Solutions2023-07-25
ViewFlex™ Eco Reprocessed ICE Catheter (K231588)ABBOTT MEDICAL2023-06-30
Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (K230584)Vein 360, LLC2023-06-06
ViewFlex™ Eco Reprocessed ICE Catheter (K230934)ABBOTT MEDICAL2023-05-03
NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K223026)Northeast Scientific, Inc.2023-02-03
ViewFlex Xtra Reprocessed ICE Catheter (K222217)ABBOTT MEDICAL2022-12-19
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K210655)Innovative Health, LLC2022-05-25
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K202042)Innovative Health, LLC2020-11-20
Reprocessed ViewFlex™ Xtra ICE Catheter (K190478)Sterilmed, Inc.2019-11-14
Reprocessed ViewFlex Xtra ICE Catheter (K182238)Stryker Sustainability Solutions2019-05-08
Reprocessed Visions PV .035 Digital IVUS Catheter (K181126)Innovative Health, LLC2019-01-18
Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K173262)Innovative Health, LLC2018-03-06
Reprocessed AcuNav Diagnostic Ultrasound Catheter (K163560)Innovative Health, LLC2017-07-12
Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter (K170474)Innovative Health, LLC2017-06-16
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters (K161700)Sterilmed, Inc.2016-11-21
Reprocessed Diagnostic Ultrasound Catheter (K153090)Innovative Health, LLC2016-03-10
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER (K121913)Stryker Sustainability Solutions, Inc.2012-12-20
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER (K110076)Sterilmed, Inc.2011-08-18
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 (K092425)Ascent Healthcare Solutions2009-10-21
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER (K063076)Ascent Healthcare Solutions2007-03-29
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER (K033436)Alliance Medical Corp.2005-03-16
STERILEMED REPROCESSED IVUS IMAGING CATHETER (K043453)Sterilmed, Inc.2005-03-01
REPROCESSED IMAGING CATHETERS (K012537)Sterilmed, Inc.2002-10-11

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Every clearance here is in the API, with alerts when new ones post.