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510(k) K897184

3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS by Cathlab Corp. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1990
Date Received
December 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Cathlab Corp.

  • K910917 — CATHLAB SILICONE BILIARY BALLOON CATHETER (August 2, 1991)
  • K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETER (June 24, 1991)
  • K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER (February 25, 1991)
  • K897051 — MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH (March 16, 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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