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510(k) K915423

HEMO-CATH SILICONE ACCESS CATHETER by Medical Components, Inc. — Product Code LFJ

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 2, 1993
Date Received
December 2, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Subclavian
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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Other clearances for product code LFJ

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  • K913468 — ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY (March 24, 1994)
  • K920634 — SPLITTABLE SHEATH INTRODUCER SET (January 14, 1994)
  • K931120 — COAXIAL ACUTE CATHETER (January 14, 1994)
  • K914162 — VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (July 1, 1993)
  • K914826 — AKCESS-CATH KIT (April 10, 1992)
  • K910501 — PERMANENT SILICONE CATHETERS (April 29, 1991)
  • K905080 — MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER (January 31, 1991)