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510(k) K940198

L-CATH CONNECTOR ASSEMBLY by Luther Medical Products, Inc. — Product Code GCD

K940198 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "L-CATH CONNECTOR ASSEMBLY". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code GCD (Connector, Catheter), a Class I device regulated under 21 CFR 878.4200. Luther Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
January 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
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)
  • 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)

Other clearances for product code GCD

  • K952470 — ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. (November 28, 1995)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K851196 — INCISION DRAIN (June 4, 1985)
  • K851921 — Y CONNECTOR (May 17, 1985)
  • K760382 — CONNECTORS (November 2, 1976)
  • K760524 — CATHETER CONNECTOR, ARGYLE TUBING (November 2, 1976)
  • K760203 — TUBE, STERILE NON-CONDUCTIVE CONNECTING (July 19, 1976)

FDA data resources