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)
Top companies in OBJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Volcano Corporation | 14 | 10 |
| Boston Scientific | 12 | 2 |
| Siemens Medical Solutions USA, Inc. | 12 | 1 |
| Biosense Webster | 9 | 1 |
| ARROW INTERNATIONAL, LLC | 0 | 6 |
| Vasonova, Inc. | 5 | 1 |
| Acist Medical Systems, Inc. | 3 | 1 |
| Conavi Medical, Inc. | 2 | 1 |
| Philips Image Guided Therapy Corporation | 3 | 0 |
| ABBOTT MEDICAL | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW 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 |
OBJ | K132133 |
| Jul 30, 2025 | Volcano 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 |
OBJ | K150442 K152829 |
| Apr 23, 2025 | Conavi 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 |
OBJ | K172258 |
| Mar 28, 2024 | Boston Scientific Corporation OptiCross Coronary Imaging Catheter, REF H749518080120 Open, Classified |
OBJ | K123621 K213593 |
| May 13, 2022 | Volcano Corp Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797 Open, Classified |
OBJ | K153094 |
| May 13, 2022 | Volcano Corp Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797 Open, Classified |
OBJ | K121273 |
| Mar 4, 2021 | Acist 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 |
OBJ | K193183 |
| Aug 24, 2020 | Boston 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 |
OBJ | K200733 |
| May 22, 2020 | Siemens Medical Solutions USA, Inc. ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F Terminated |
OBJ | K173618 |
| Oct 17, 2018 | Volcano 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 |
OBJ | K153094 |
| Oct 17, 2018 | Volcano 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 |
OBJ | K121273 |
| Apr 11, 2018 | Arrow International Inc ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM Terminated |
OBJ | K132133 |
| Nov 3, 2017 | Volcano 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 |
OBJ | K071554 K123898 |
| Jun 1, 2017 | Arrow 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 |
OBJ | K103255 |
| Apr 28, 2017 | Arrow International Inc Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters Terminated |
OBJ | K103255 |
| Apr 10, 2017 | Volcano 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 |
OBJ | K160583 |
| Apr 10, 2017 | Volcano 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 |
OBJ | K160583 |
| Apr 25, 2016 | Volcano 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 |
OBJ | K071554 K123898 |
| Oct 1, 2015 | Biosense 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 |
OBJ | K140318 |
| Aug 31, 2015 | Arrow 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 |
OBJ | K073451 K103255 +2 |
| Jun 25, 2015 | Volcano 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 |
OBJ | K121273 |
| Apr 9, 2015 | VasoNova, 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 |
OBJ | K123813 |
| Jan 29, 2015 | Arrow International Inc Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing Terminated |
OBJ | K121941 K122545 |
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