Atlas FDA

OptiCross X, 40 MHz Coronary Imaging Catheter

FDA 510(k) clearance K161125 · decided 2016-05-19

Clearance details

K-number
K161125
Device name
OptiCross X, 40 MHz Coronary Imaging Catheter
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2016-04-21
Decision date
2016-05-19
Days to decision
28 days
Clearance type
Special
Product code
OBJ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
VERAFEYE Imaging Catheter (VF-VIC-002) (K261849)Luma Vision Limited2026-07-24
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OptiCross 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) (K260816)Boston Scientific2026-04-08
Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter (K253399)Volcano Corporation (Dba Philips Image Guided Therapy Device2025-10-28
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TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System (K250913)Jiangsu Tingsn Technology Co., Ltd.2025-07-19
ViewFlex™ 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™ (K251211)ABBOTT MEDICAL2025-05-23
ViewFlex™ X ICE Catheter, Sensor Enabled™ (K251231)ABBOTT MEDICAL2025-05-20
VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103)Philips Image Guided Therapy Corporation2025-05-09
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NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540)Biosense Webster, Inc.2024-06-28
SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050)Biosense Webster, Inc.2024-06-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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