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510(k) K897051

MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH by Cathlab Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1990
Date Received
December 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
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)
  • 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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