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510(k) K012520

GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E by Cardiac Assist Devices, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2002
Date Received
August 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Cardiac Assist Devices, Inc.

  • K960849 — MAGNO ALARM (March 26, 1997)
  • K955847 — GYRO TIP EP CATHETER (January 29, 1997)

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