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TurboHawk THS-LX-C

by Covidien LP

TurboHawk THS-LX-C is a Class II device made by Covidien LP, cleared under FDA 510(k) K111723 on 27 Oct 2011 and listed in FDA GUDID since 12 Oct 2015 (UDI-DI 00821684047200), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K111723

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00821684047200 UDI-DI Date12 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111723 Date27 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111723 decided 27 Oct 2011 Active
  • FDA GUDID UDI-DI 00821684047200 listed 12 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-3022-2018 FDA Class II initiated 10 Aug 2018

    The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.

Timeline

3 dated events

  1. Cleared FDA 510(k) K111723
  2. Listed FDA GUDID 00821684047200
  3. Recall initiated FDA recalls Z-3022-2018

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TurboHawk
Generic name
Mechanical atherectomy system catheter, peripheral
Model / reference
THS-LX-C
Primary DI / UDI-DI
00821684047200
510(k) Number
FDA product code
MCW
GMDN term
Mechanical atherectomy system catheter, peripheral
Device class
Class II
Regulation number
870.4875
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mechanical atherectomy system catheter, peripheral

Cleared under the same submission (K111723)

and 1 more cleared under K111723

Similar devices

Other devices filed under FDA product code MCW (Catheter, peripheral, atherectomy).

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)