Modified Label Change to Model 5455 Surgical Cable

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K885171 ↗

FDA Product Code

DRO

Device Class

Class II

Regulation

21 CFR Part 870.5550

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Direct Current Bone Growth Stim. an. Pad

  Not classified

  FDA 510(k) K810271 Active Cleared 19 Feb 1981

• Canmed 451

  Class II

  FDA 510(k) K905729 Active Cleared 7 Feb 1991

• 2700 Cleartrace Radiotranslucent Monitoring ECG Electrobe

  Class II

  FDA 510(k) K944849 Active Cleared 17 Oct 1994

• Holter Kit Model #5000 Series

  Class II

  FDA 510(k) K823414 Active Cleared 30 Dec 1982

• Thermal Dilution Catheter

  Class II

  FDA 510(k) K843411 Active Cleared 18 Oct 1984

• Disposable Surgical Cable

  Class II

  FDA 510(k) K941839 Active Cleared 27 Jul 1994

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