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510(k) K955847

GYRO TIP EP CATHETER by Cardiac Assist Devices, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1997
Date Received
December 26, 1995
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.

  • K012520 — GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E (March 27, 2002)
  • K960849 — MAGNO ALARM (March 26, 1997)

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