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)
Top companies in MCW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2025 | Bard 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 |
MCW | K172315 K211738 +1 |
| Dec 27, 2024 | Angiodynamics, Inc. AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 Open, Classified |
MCW | K241553 |
| Dec 16, 2024 | Spectranetics 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 |
MCW | K123632 K170059 |
| Dec 8, 2023 | Spectranetics 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 |
MCW | K170059 |
| Mar 7, 2022 | ev3 Inc. Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. Terminated |
MCW | K212027 |
| Mar 7, 2022 | ev3 Inc. Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature. Terminated |
MCW | K212027 |
| Jan 19, 2022 | ev3 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 |
MCW | K161361 |
| Jan 19, 2022 | ev3 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 |
MCW | K161361 |
| Jul 21, 2021 | Cardiovascular Systems Inc STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO Terminated |
MCW | K190634 |
| Jul 21, 2021 | Cardiovascular Systems Inc DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 Terminated |
MCW | K190634 |
| Aug 10, 2018 | Micro 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 |
MCW | K111723 |
| Sep 14, 2017 | Cardiovascular 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 |
MCW | K152694 |
| Sep 14, 2017 | Cardiovascular 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 |
MCW | K152694 |
| Jul 14, 2017 | Spectranetics 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 |
MCW | K170059 |
| Apr 10, 2017 | Boston 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 |
MCW | K133023 |
| Apr 10, 2017 | Cardiovascular 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 |
MCW | K151260 |
| Mar 3, 2017 | Cardiovascular 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 |
MCW | K151260 |
| Feb 22, 2017 | Cardiovascular 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 |
MCW | K152694 |
| Nov 28, 2016 | Spectranetics 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 |
MCW | K140775 |
| Jun 13, 2016 | Cardiovascular 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 |
MCW | K090521 |
| Feb 5, 2016 | Spectranetics 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 |
MCW | K152181 |
| Aug 14, 2014 | Cardiovascular 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 |
MCW | K133399 |
| Apr 18, 2013 | Elana, 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 |
MCW | None listed |
| Jul 9, 2012 | Cardiovascular 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 |
MCW | K110389 |
| Mar 18, 2010 | Ev3, 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 |
MCW | K061188 |
| Sep 10, 2009 | Cardiovascular 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 |
MCW | K071427 K090521 |
| Jun 24, 2009 | Arrow International Inc Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts Terminated |
MCW | K990829 |
| Apr 17, 2009 | Cardiovascular 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 |
MCW | K071427 |
| Oct 31, 2008 | Cordis 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 |
MCW | K001577 K014117 +3 |
| Jul 23, 2007 | Kensey Nash Corp ThromCat Thrombectomy Catheter System. Catalog number 63000-01 Terminated |
MCW | K060016 |
| Mar 8, 2007 | Kensey 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 |
MCW | K060016 |
| Jun 14, 2006 | Ev3, 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 |
MCW | K021096 |
| Jun 14, 2006 | Ev3, 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 |
MCW | K021096 |
| Aug 7, 2004 | Datascope Interventional Products Division ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton. Terminated |
MCW | K031610 |
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