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510(k) K942103

L-CATH CATHETER SYSTEM - PORT L-CATH by Luther Medical Products, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1994
Date Received
May 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Luther Medical Products, Inc.

  • K982797 — BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (November 30, 1998)
  • K980090 — ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) (March 24, 1998)
  • K974543 — L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 (February 10, 1998)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (December 15, 1994)
  • K930473 — ONECATH L-CATH CATHETER SYSTEM (April 7, 1994)
  • K925236 — L CATH(R) CATHETER SYSTEM (March 22, 1994)
  • K920755 — L-CATH PEEL AWAY SYSTEM CATHETER (June 7, 1993)
  • K925979 — DUAL LUMEN L-CATH CATHETER SYSTEM (May 27, 1993)
  • K924968 — L-CATH PEEL-AWAY CATHETER SYSTEM (May 21, 1993)
  • K924562 — CATHETER INTRODUCER (February 25, 1993)

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