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510(k) K143701

Device
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM
Applicant
VOLCANO CORPORATION
510(k) number
K143701
Product code
OBJ  
Decision
Substantially Equivalent (SESE)
Decision date
2015-08-26
Date received
2014-12-24
Regulation
870.1200
Classification name
Catheter, Ultrasound, Intravascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARCUS GARCIA
Address
3721 Valley Centre Dr., Suite 500 San Diego CA US 92130 92130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252945Novasight Hybrid SystemConavi Medical, Inc.2026-04-17
K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific2026-04-08
K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device2025-10-28
K250955XC11 ICE System, USAYorlabs, Inc.2025-10-22
K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.2025-07-19
K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ABBOTT MEDICAL2025-05-23
K251231ViewFlex™ X ICE Catheter, Sensor Enabled™ABBOTT MEDICAL2025-05-20
K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)Philips Image Guided Therapy Corporation2025-05-09
K242893VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging SystemLuma Vision Limited2025-03-24
K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.2024-06-28
K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterBiosense Webster, Inc.2024-06-12
K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.2024-04-23
K233270AcuNav Crystal Ultrasound CatheterSiemens Medical Solutions USA, Inc.2023-10-28
K230453OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterBoston Scientific Corporation2023-05-18
K223766NUVISION™ NAV Ultrasound CatheterBiosense Webster, Inc.2023-02-16

Legacy Summary#

summary

FDA Review#

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