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510(k) K011988

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C by Cardiofocus, Inc. — Product Code OCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2001
Date Received
June 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Other clearances by Cardiofocus, Inc.

  • K152310 — HeartLight Deflectable Sheath (February 24, 2016)
  • K013201 — CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (March 18, 2002)
  • K013901 — MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (December 20, 2001)
  • K993834 — SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (February 4, 2000)

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