510(k) K250955

Device: XC11 ICE System, USA
Applicant: Yorlabs, Inc.
510(k) number: K250955
Product code: OBJ
Decision: Substantially Equivalent (SESE)
Decision date: 2025-10-22
Date received: 2025-03-31
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: N

Related Records

Applicant Contact

Contact: Wanda Carpinella
Address: 2210 Faraday Ave., Suite 100 Carlsbad CA US 92008 92008

FDA Registration Numbers

3031397684
3005877899
9710602
3035950510
1061124
3032109181
3009350690
3005467144
3012833053
3006985147
3009077524
3019216
2134265
3017060084
3017461134
3033527283
3008516548
9617277
1225687
3002619337
3013162291
3011416394
3010952312
3005334138
3016171942
3003594449
3023245
3032807464
2518586
3033508292
1058584
3007738736
3016076141
1000601180
3013300026
3007695959
3008363989
3015276088
3010398867
3015859709
2090040
3014745562
3038718997
3013403214
9612283
3033527241
3013734919
9673241
2939520
3017894900
3000126629
2030624
3010432890
3009490946
3009537152
9610482
3008497357
2032112
8043817
3009888344
3010273872
3012198618
3012127758
2531814
3038966633
3015551113
8010026
9681834
3019807891
3003898360
2029275
2032350
2024311
2124215
3013944123
3009196578
3012179728
3003493679
3014272734
3010041511

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OBJ

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K252945	Novasight Hybrid System	Conavi Medical, Inc.	2026-04-17
K260816	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)	Boston Scientific	2026-04-08
K253399	Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter	Volcano Corporation (Dba Philips Image Guided Therapy Device	2025-10-28
K250913	TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System	Jiangsu Tingsn Technology Co., Ltd.	2025-07-19
K251211	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	ABBOTT MEDICAL	2025-05-23
K251231	ViewFlex X ICE Catheter, Sensor Enabled	ABBOTT MEDICAL	2025-05-20
K251103	VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)	Philips Image Guided Therapy Corporation	2025-05-09
K242893	VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System	Luma Vision Limited	2025-03-24
K241540	NUVISION Ultrasound Catheter; NUVISION NAV Ultrasound Catheter	Biosense Webster, Inc.	2024-06-28
K240050	SOUNDSTAR CRYSTAL Ultrasound Catheter	Biosense Webster, Inc.	2024-06-12
K233948	Provisio SLT IVUS System	Provisio Medical, Inc.	2024-04-23
K233270	AcuNav Crystal Ultrasound Catheter	Siemens Medical Solutions USA, Inc.	2023-10-28
K230453	OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter	Boston Scientific Corporation	2023-05-18
K223766	NUVISION NAV Ultrasound Catheter	Biosense Webster, Inc.	2023-02-16
K223077	ViewFlex Xtra ICE Catheter	Irvine Biomedical, A St. Jude Medical Company	2022-12-07