Atlas FDA

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

FDA 510(k) clearance K213593 · decided 2022-01-14

Clearance details

K-number
K213593
Device name
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2021-11-12
Decision date
2022-01-14
Days to decision
63 days
Clearance type
Special
Product code
OBJ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
Novasight Hybrid System (K252945)Conavi Medical, Inc.2026-04-17
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
XC11 ICE System, USA (K250955)Yorlabs, Inc.2025-10-22
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
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System (K242893)Luma Vision Limited2025-03-24
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

RecordFirmDate
OptiCross Coronary Imaging Catheter, REF H749518080120 recall (Z-1396-2024)Boston Scientific Corporation2024-03-28

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P180046/S113)Boston Scientific Corporation2026-08-07
Axonics Sacral Neuromodulation System (P190006/S113)Boston Scientific Corporation2026-08-07
Innova™ Self Expanding Stent System (P140028/S087)Boston Scientific Corporation2026-08-06
Ranger™ Paclitaxel-Coated Balloon Catheter (P190019/S043)Boston Scientific Corporation2026-08-04
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S009)Boston Scientific Corporation2026-07-30
Axonics Sacral Neuromodulation System (P180046/S110)Boston Scientific Corporation2026-07-24
Axonics Sacral Neuromodulation System (P190006/S110)Boston Scientific Corporation2026-07-24
S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219) (P110042/S215)Boston Scientific Corporation2026-07-23