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510(k) K983927

GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT by Arterial Vascular Engineering, Inc. — Product Code DQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1999
Date Received
November 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Occluder, Catheter Tip
Device Class
Class II
Regulation Number
870.1370
Review Panel
CV
Submission Type

Other clearances by Arterial Vascular Engineering, Inc.

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  • K971295 — AVE BRIDGE STENT SYSTEM (November 5, 1997)

Other clearances for product code DQT

  • K945963 — THE OMNIGUIDE GUIDING CATHETER WITH BALLOON (February 8, 1995)
  • K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETER (June 24, 1991)
  • K910339 — AVD INTIMAX OCCLUSION CATHETER (May 29, 1991)
  • K880860 — CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015 (May 26, 1988)
  • K880231 — MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER (May 25, 1988)
  • K872090 — THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT (October 30, 1987)
  • K872790 — PERFUSION CATHETER (September 15, 1987)
  • K872154 — MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH (August 3, 1987)
  • K863559 — URESIL OCCLUSION BALLOON CATHETER (October 10, 1986)
  • K844918 — OCCLUSION & OCCLUSION-IRRIGATION (August 5, 1985)