Reprocessed Intravascular Ultrasound Catheter

Product Code: OWQ

Cardiovascular Diagnostic Ultrasound Devices

Definition: For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.1200


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as OWQ

957Reprocessed Intravascular Ultrasound CatheterDiagnostic Intravascular Catheter.

Total Product Life Cycle (TPLC) Devices

957Reprocessed Intravascular Ultrasound CatheterDiagnostic Intravascular Catheter.

FDA Consensus Standards

Reprocessed Intravascular Ultrasound Catheter [32412]21 CFR §870.1200 🔎

Pre-market Notifications for OWQ

K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC.
K190478Reprocessed ViewFlexâ„¢ Xtra ICE CatheterSterilmed, Inc.
K182238Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions
K181126Reprocessed Visions PV .035 Digital IVUS CatheterInnovative Health, LLC
K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, Llc.
K170474Reprocessed SoundStar 3D Diagnostic Ultrasound CatheterInnovative Health, LLC.
K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC.
K161700SoundStar Eco 8F 3D Diagnostic Eco Ultrasound Catheters, SoundStar Eco 8F G 3D Diagnostic Eco Ultrasound CathetersSTERILMED, INC.
K153090Reprocessed Diagnostic Ultrasound CatheterINNOVATIVE HEALTH, LLC
K121913REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETERSTRYKER SUSTAINABILITY SOLUTIONS, INC.
K110076REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERSTERILMED, INC.
K092425REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10ASCENT HEALTHCARE SOLUTIONS
K063076REPROCESSED DIAGNOSTIC ULTRASOUND CATHETERASCENT HEALTHCARE SOLUTIONS
K043453STERILEMED REPROCESSED IVUS IMAGING CATHETERSTERILMED, INC.
K033436REPROCESSED DIAGNOSTIC ULTRASOUND CATHETERALLIANCE MEDICAL CORP.

Global Unique Device Identification Database

00885825020958Reprocessed intravascular ultrasound catheter
00885825020941Reprocessed intravascular ultrasound catheter
00885825020927Reprocessed intravascular ultrasound catheter
00885825020910Reprocessed intravascular ultrasound catheter
00885825011376Reprocessed intravascular ultrasound catheter
00885825011369Reprocessed intravascular ultrasound catheter
00885825011352Reprocessed intravascular ultrasound catheter
00885825011338Reprocessed intravascular ultrasound catheter
00885825002350Reprocessed intravascular ultrasound catheter
00885825002343Reprocessed intravascular ultrasound catheter
00885825002336Reprocessed intravascular ultrasound catheter
00885825002329Reprocessed intravascular ultrasound catheter
10888551045094Reprocessed intravascular ultrasound catheter
10888551045087Reprocessed intravascular ultrasound catheter
10888551044387Reprocessed intravascular ultrasound catheter

Maude Adverse Events

NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2020-03-23
NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2020-03-09
NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2020-03-06
NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2020-03-06
NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2020-02-06
IMAGING CATHETERSTERILMED, INC.2019-08-20
SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERSTERILMED, INC.2019-04-08
N/A REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER, 8FSTERILMED, INC.2019-04-08
N/A DIAGNOSTIC ULTRASOUND CATHETER, 8FSTERILMED, INC.2019-04-08
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER, 8FSTERILIMED, INC2019-04-08
REPROCESSED SOUNDSTAR ECO CATHETERSTERILMED, INC.2019-03-26
N/AREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2018-04-24
N/AIMAGING CATHETERSTERILMED, INC.2018-04-20
N/AIMAGING CATHETERSTERILMED, INC.2017-11-20
ACUSONSTERILMED, INC.2017-08-28
NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2016-06-23
NAREPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2016-06-23
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2016-05-17
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2016-05-17
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2016-04-11
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2015-10-23
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2015-09-24
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2015-08-31
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2015-06-01
REPROCESSED INTRAVASCULAR ULTRASOUND CATHETERSTERILMED, INC.2015-04-09
ACUNAV DX ULTRASOUND CATHETERSTERILMED2015-01-16
NAREPROCESSED INTRAVASCULAR ULTRASOUNDSTERILMED, INC.2014-11-20
NAREPROCESSED INTRAVASCULAR ULTRASOUNDSTERILMED, INC.2014-10-17
NASTERILMED, INC.2013-10-11
ACUNAVSTERILMED, INC.2013-09-04
ACUNAVSTRYKER SUSTAINABILITY SOLUTIONS2013-07-19
3DNLISTRYKER SUSTAINABILITY SOLUTIONS PHOENIX2013-01-28

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