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510(k) K842147

CATH-TECH CHOLANGIOGRAPHY CATHETER by Catheter Technology Corp. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1984
Date Received
May 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Catheter Technology Corp.

  • K880571 — CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM (March 4, 1988)
  • K871080 — PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (August 12, 1987)
  • K871998 — GROSHONG CV CATHETER REPAIR KIT (June 24, 1987)
  • K860256 — BRAWN AND GROSHONG CATHETERS (March 28, 1986)
  • K842577 — CATH-TECH POLYURETHANE UMBILICAL VESS (March 13, 1985)
  • K840339 — UMBILICAL VESSEL CATHETER (July 25, 1984)
  • K831386 — GROSHONG CATHETER, LONG TERM TYPE (October 14, 1983)
  • K831365 — TESTCORP ANA (June 2, 1983)
  • K831366 — TESTCORP PREG (June 2, 1983)
  • K831361 — BETA-PREG (June 2, 1983)

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