Vszl IPN914178

• FDA 510(k) K100093 decided 30 Apr 2010 Active
• FDA GUDID UDI-DI 10841156101329 listed 8 Nov 2018 Listed

1. 30 Apr 2010 Cleared FDA 510(k) K100093
2. 8 Nov 2018 Listed FDA GUDID 10841156101329

Trade name

Vszl

Generic name

Torque manipulation device

Model / Ref / Catalog

IPN914178, 8181

Primary DI / UDI-DI

10841156101329

510(k) Number

K100093 ↗

FDA product code

DQX

GMDN term

Torque manipulation device

Device class

Class II

Regulation number

870.1330

GUDID distribution status

In Commercial Distribution

Category: Torque manipulation device

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• Cook G00423 THSF-35-260 by COOK INCORPORATED
• Approach G52938 HMW-14-190-ST by COOK INCORPORATED
• Gtx Guidewire, Models Tbd-Gtx 1, 3, 6, 9, 12, 15 by MEDTRONIC VASCULAR, INC.
• Pre-Formed Blue by Lake Region Medical
• Crosslead 0.018inch by ASAHI INTECC CO., LTD.
• GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 by Biotronik, Inc.

• Arrow IPNB00820 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00826 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00822 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

• Arrow IPNB00827 Open recall

  Class II

  FDA 510(k) K140110 Active Cleared 27 Mar 2015 GUDID on market

See all devices from Teleflex Incorporated →