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510(k) K881455

EMBOLECTOMY CATHETER(MODIFIED) by Cathlab Corp. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1988
Date Received
April 6, 1988
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.

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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)

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