ClearanceBrief
Panels › Cardiovascular › Product code OBJ · Class 2

Catheter, Ultrasound, Intravascular

Regulation 870.1200

4510(k)s in 12 months (80 all time)
1recalls in 12 months (23 all time)
23recalls that name a 510(k)
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Top companies in OBJ

DateFirm and productCodeLinked 510(k)
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X
Open, Classified
OBJK132133
Jul 30, 2025Volcano Corp
Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
Open, Classified
OBJK150442
K152829
Apr 23, 2025Conavi Medical Inc.
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasi
Open, Classified
OBJK172258
Mar 28, 2024Boston Scientific Corporation
OptiCross Coronary Imaging Catheter, REF H749518080120
Open, Classified
OBJK123621
K213593
May 13, 2022Volcano Corp
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Open, Classified
OBJK153094
May 13, 2022Volcano Corp
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
Open, Classified
OBJK121273
Mar 4, 2021Acist Medical Systems
ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examina
Terminated
OBJK193183
Aug 24, 2020Boston Scientific Corporation
Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104
Terminated
OBJK200733
May 22, 2020Siemens Medical Solutions USA, Inc.
ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
Terminated
OBJK173618
Oct 17, 2018Volcano Corporation
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0200.272 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultra
Terminated
OBJK153094
Oct 17, 2018Volcano Corporation
Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0200.173 Product Usage: The Volcano PV .035 Digital IVUS Catheter is an over the wire imaging catheter with a digital ultra
Terminated
OBJK121273
Apr 11, 2018Arrow International Inc
ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
Terminated
OBJK132133
Nov 3, 2017Volcano Corporation
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07
Terminated
OBJK071554
K123898
Jun 1, 2017Arrow International Inc
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market availa
Terminated
OBJK103255
Apr 28, 2017Arrow International Inc
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Terminated
OBJK103255
Apr 10, 2017Volcano Corporation
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (R
Terminated
OBJK160583
Apr 10, 2017Volcano Corporation
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or
Terminated
OBJK160583
Apr 25, 2016Volcano Corporation
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qua
Terminated
OBJK071554
K123898
Oct 1, 2015Biosense Webster, Inc.
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other device
Terminated
OBJK140318
Aug 31, 2015Arrow International Inc
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Terminated
OBJK073451
K103255 +2
Jun 25, 2015Volcano Corporation
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by provi
Terminated
OBJK121273
Apr 9, 2015VasoNova, Inc.
VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
Terminated
OBJK123813
Jan 29, 2015Arrow International Inc
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Terminated
OBJK121941
K122545

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