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510(k) K925979

DUAL LUMEN L-CATH CATHETER SYSTEM by Luther Medical Products, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
November 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
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)
  • 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)
  • K924968 — L-CATH PEEL-AWAY CATHETER SYSTEM (May 21, 1993)
  • K924562 — CATHETER INTRODUCER (February 25, 1993)

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