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510(k) K980090

ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) by Luther Medical Products, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1998
Date Received
January 9, 1998
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 Luther Medical Products, Inc.

  • K982797 — BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (November 30, 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)
  • K942103 — L-CATH CATHETER SYSTEM - PORT L-CATH (July 26, 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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