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510(k) K910315

PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K by Sorex Medical — Product Code LJS

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 5, 1991
Date Received
January 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Sorex Medical

  • K923843 — FOGLESS (March 25, 1994)
  • K913036 — PLUME MASTER (September 6, 1991)
  • K911070 — PICC-FIX (July 5, 1991)
  • K911150 — SOREX SAFE-AIR (June 28, 1991)
  • K905572 — EDLICH WOUND MANAGEMENT TRAY (March 12, 1991)
  • K903740 — TRACH-EZE (December 6, 1990)
  • K902410 — MEDICAL PROCEDURE TRAY (November 20, 1990)
  • K885136 — GRAFT GUARD (February 6, 1989)

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