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510(k) K910916

CATHLAB SILICONE OCCLUSION BALLOON CATHETER by Cathlab Corp. — Product Code DQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
March 5, 1991
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 Cathlab Corp.

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  • K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER (February 25, 1991)
  • K897051 — MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH (March 16, 1990)
  • K897184 — 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS (March 14, 1990)
  • K893435 — SILICONE FLOW-DIRECTED THERMODILUTION CATHETER (September 26, 1989)
  • K893680 — SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. (August 1, 1989)
  • K881455 — EMBOLECTOMY CATHETER(MODIFIED) (June 15, 1988)

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  • 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)