510(k) K242757

Device: Rotarex Atherectomy System
Applicant: Bard Peripheral Vascular, Inc.
510(k) number: K242757
Product code: MCW
Decision: Substantially Equivalent (SESE)
Decision date: 2025-01-30
Date received: 2024-09-12
Regulation: 870.4875
Classification name: Catheter, Peripheral, Atherectomy
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Related Records

Applicant Contact

Contact: Aaron Conovaloff
Address: 1625 W. 3rd St. Tempe AZ US 85281 85281

FDA Registration Numbers

3002631703
3007048256
2024311
3016257349
3003708554
2183744
2134265
3010173425
3007284006
2015691
3012669557
3015124694
9616684
3003862657
2244478
3004091615
3003780911
3014254831
2183870
3008363989
3008814558
9612164
2939520
3010273872
3006946276
3000279201
2124215
3002807314
3020968442
1625425
2020394
1721676
1000121056
3009756153
1724474
3032916632
3008439199
1643817
3006702495
3017896194
2011171
2648045
3011137372
3004742232
3014443747
3000126629
3010280625
1061124
3004859241
3038165043
3010041511
3016445722
1225687

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MCW

510(k)	Device	Applicant	Decision date
K260244	Auryon Atherectomy System	Eximo Medical	2026-04-10
K250723	FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)	Cardio Flow Inc.,	2025-04-25
K250385	Turbo-Elite Laser Atherectomy Catheter	Spectranetics	2025-03-13
K242947	FreedomFlow Orbital Circumferential Atherectomy System	Cardio Flow Inc.,	2024-11-05
K241553	Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating	Eximo Medical, Ltd.	2024-06-27
K233483	FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)	Cardio Flow Inc.,	2024-02-15
K233668	Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)	Eximo Medical, Ltd.	2023-12-15
K231538	FreedomFlow Orbital Circumferential Atherectomy System	Cardio Flow Inc.,	2023-09-27
K230709	Auryon Atherectomy System	Eximo Medical, Ltd.	2023-06-09
K230005	Pantheris LV Atherectomy Catheter	Avinger, Inc.	2023-06-06
K222837	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	Spectranetics, Inc.	2022-12-08
K220116	Auryon Atherectomy Catheters	Eximo Medical, Ltd.	2022-09-26
K220962	ROTAPRO Rotational Atherectomy System	Boston Scientific Corporation	2022-09-06
K221077	Auryon Atherectomy System	Eximo Medical, Ltd.	2022-06-09
K220568	Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	Cardiovascualr Systems, Inc.	2022-04-27