ClearanceBrief
Panels › Cardiovascular › Product code MCW · Class 2

Catheter, Peripheral, Atherectomy

Regulation 870.4875

1510(k)s in 12 months (146 all time)
0recalls in 12 months (34 all time)
33recalls that name a 510(k)
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Top companies in MCW

DateFirm and productCodeLinked 510(k)
Mar 5, 2025Bard Peripheral Vascular Inc
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Open, Classified
MCWK172315
K211738 +1
Dec 27, 2024Angiodynamics, Inc.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Open, Classified
MCWK241553
Dec 16, 2024Spectranetics Corporation
Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-
Open, Classified
MCWK123632
K170059
Dec 8, 2023Spectranetics Corporation
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter
Open, Classified
MCWK170059
Mar 7, 2022ev3 Inc.
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Terminated
MCWK212027
Mar 7, 2022ev3 Inc.
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Terminated
MCWK212027
Jan 19, 2022ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional ather
Terminated
MCWK161361
Jan 19, 2022ev3 Inc.
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne directional ath
Terminated
MCWK161361
Jul 21, 2021Cardiovascular Systems Inc
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Terminated
MCWK190634
Jul 21, 2021Cardiovascular Systems Inc
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Terminated
MCWK190634
Aug 10, 2018Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
Terminated
MCWK111723
Sep 14, 2017Cardiovascular Systems Inc
Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acce
Terminated
MCWK152694
Sep 14, 2017Cardiovascular Systems Inc
Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acce
Terminated
MCWK152694
Jul 14, 2017Spectranetics Corporation
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Terminated
MCWK170059
Apr 10, 2017Boston Scientific Corporation
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located
Terminated
MCWK133023
Apr 10, 2017Cardiovascular Systems Inc
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Periphe
Terminated
MCWK151260
Mar 3, 2017Cardiovascular Systems Inc
ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radio
Terminated
MCWK151260
Feb 22, 2017Cardiovascular Systems Inc
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patien
Terminated
MCWK152694
Nov 28, 2016Spectranetics Corporation
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics
Terminated
MCWK140775
Jun 13, 2016Cardiovascular Systems Inc
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI
Terminated
MCWK090521
Feb 5, 2016Spectranetics Corp.
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System.
Terminated
MCWK152181
Aug 14, 2014Cardiovascular Systems, Inc.
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System i
Terminated
MCWK133399
Apr 18, 2013Elana, Inc.
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Terminated
MCWNone listed
Jul 9, 2012Cardiovascular Systems, Inc.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is
Terminated
MCWK110389
Mar 18, 2010Ev3, Inc.
SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at
Terminated
MCWK061188
Sep 10, 2009Cardiovascular Systems, Inc.
Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA.
Terminated
MCWK071427
K090521
Jun 24, 2009Arrow International Inc
Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts
Terminated
MCWK990829
Apr 17, 2009Cardiovascular Systems, Inc.
Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWi
Terminated
MCWK071427
Oct 31, 2008Cordis Corporation
Outback LTD Re-Entry Catheter, Sterile, Single Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for placement and positioning of guidewires within the peripheral vasculature. The can
Terminated
MCWK001577
K014117 +3
Jul 23, 2007Kensey Nash Corp
ThromCat Thrombectomy Catheter System. Catalog number 63000-01
Terminated
MCWK060016
Mar 8, 2007Kensey Nash Corp
ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus
Terminated
MCWK060016
Jun 14, 2006Ev3, Inc
X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3
Terminated
MCWK021096
Jun 14, 2006Ev3, Inc
X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1150-45 (for US distribution). Model number XR-CS1150-45 (for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas. ev3
Terminated
MCWK021096
Aug 7, 2004Datascope Interventional Products Division
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton.
Terminated
MCWK031610

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