Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K982657 ↗

FDA Product Code

MCW

Models / Variants

Atd 601

Atd 602

Atd 801

Atd 802

Foot Pedal Assembly Model Ak 100

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Ultra-Select Guidewire, Hytek Guidewire

  Class II

  FDA 510(k) K991898 Active Cleared 16 Jun 1999

• Amplatz Thrombectomy Device(Atd 603, 602, 801, 802)/Foot Pedal Assembly(Ak 200)

  Class II

  FDA 510(k) K971984 Active Cleared 19 Sep 1997

• Cricket

  Class II

  FDA 510(k) K955304 Active Cleared 16 May 1996

• Solostick (Amplatz Dilator Needle)

  Class II

  FDA 510(k) K896096 Active Cleared 10 Apr 1990

• Ultra-Select Ptca Guidewire

  Class II

  FDA 510(k) K910280 Active Cleared 19 Apr 1991

• Amplatz Goose Neck Snare Kit/ Catheter

  Class II

  FDA 510(k) K972511 Active Cleared 6 Mar 1998

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