SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

CARDIOFOCUS, INC.

The following data is part of a premarket notification filed by Cardiofocus, Inc. with the FDA for Surgical Lightstic 180, Model 180 L, Model 180 C.

Pre-market Notification Details

• Device ID: K011988
• 510k Number: K011988
• Device Name: SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
• Classification: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
• Applicant: CARDIOFOCUS, INC. 10 COMMERCE WAY Norton, MA 02766
• Contact: Joseph Curtis
• Correspondent: Joseph Curtis; CARDIOFOCUS, INC. 10 COMMERCE WAY Norton, MA 02766
• Product Code: OCL
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-26
• Decision Date: 2001-09-20
• Summary: summary