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510(k) K801967

MEDCOMP FEMORAL VEIN CATHETER by Medical Components, Inc. — Product Code FIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle With Uni-Directional Pump
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER (August 15, 2013)
  • K130923 — 5F DIGNITY CT TITANIUM PORT (July 31, 2013)
  • K124046 — VALVED TEARAWAY INTRODUCER GENERATION II (June 3, 2013)
  • K123617 — 3F PRO-PICC (May 15, 2013)
  • K122423 — VASU-PICC (December 12, 2012)
  • K121848 — SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT (September 21, 2012)

Other clearances for product code FIF

  • K873279 — 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (October 23, 1987)
  • K820173 — COBE SINGLE-NEEDLE CONTROLLER #18-756 (March 23, 1982)
  • K802230 — BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (December 22, 1980)
  • K792174 — MODEL DM 353 & DM-353-L SINGLE NEEDLE (November 16, 1979)
  • K772147 — GW 35 GUIDE WIRE (November 28, 1977)