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510(k) K842577

CATH-TECH POLYURETHANE UMBILICAL VESS by Catheter Technology Corp. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1985
Date Received
July 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
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)
  • K842147 — CATH-TECH CHOLANGIOGRAPHY CATHETER (October 2, 1984)
  • K840339 — UMBILICAL VESSEL CATHETER (July 25, 1984)
  • K831386 — GROSHONG CATHETER, LONG TERM TYPE (October 14, 1983)
  • K831361 — BETA-PREG (June 2, 1983)
  • K831366 — TESTCORP PREG (June 2, 1983)
  • K831365 — TESTCORP ANA (June 2, 1983)

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