Turbohawk Peropheral Plaque Excision System

510(k) Number

K103618 ↗

FDA product code

MCW

FDA applicant

Ev3, Inc.

Device class

Class II

Regulation

21 CFR Part 870.4875

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MCW (Catheter, Peripheral, Atherectomy).

• POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER, MODEL 3030C, LF140 CATHETER, MODEL 3040C, PUMP SET 3020P by Possis Medical, Inc.
• STEALTH 360 ORBITAL PAD SYSTEM by Cardiovascular Systems, Inc.
• ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS by Boston Scientific
• AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 by Microvena Corp.
• OASIS THROMBECTOMY CATHETER SYSTEM by Boston Scientific
• JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM by Medrad, Inc.
• Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system by Cardiovascular Systems, Inc.
• SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE by Foxhollow Technologies, Inc.
• Pantheris Catheter by AVINGER, INC.
• HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER by Devices For Vascular Intervention, Inc.

• EverFlex™

  Class IIb

  CE/MDD

• Liberant™ LMT-TRX

  Class II

  GUDID on market

• EverCross™ AB35W12060135

  Class II

  FDA 510(k) K190753 Active Cleared 23 Apr 2019 GUDID on market

• EverFlex™ Protégé™ EverFlex™ PRB35-08-060-120 Open recall

  Class III

  FDA PMA P110023 Active Approved 7 Mar 2012 GUDID on market

See all devices from EV3, Inc →