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510(k) K820102

SUBCLAVIAN JUGULAR CATHETER SET by Luther Medical Products, Inc. — Product Code DQR

K820102 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "SUBCLAVIAN JUGULAR CATHETER SET". The FDA issued a decision of Substantially Equivalent on Jan 29, 1982. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Luther Medical Products, Inc. has 16 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 29, 1982
Date Received
Jan 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Catheter
Device Class
Class II
Regulation Number
870.1300
Review Panel
CV
Submission Type
510(k)

Other clearances by Luther Medical Products, Inc.

  • K982797 — BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB (Nov 30, 1998)
  • K980090 — ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM) (Mar 24, 1998)
  • K974543 — L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24… (Feb 10, 1998)
  • K940198 — L-CATH CONNECTOR ASSEMBLY (Dec 15, 1994)
  • K942103 — L-CATH CATHETER SYSTEM - PORT L-CATH (Jul 26, 1994)
  • K930473 — ONECATH L-CATH CATHETER SYSTEM (Apr 7, 1994)
  • K925236 — L CATH(R) CATHETER SYSTEM (Mar 22, 1994)
  • K920755 — L-CATH PEEL AWAY SYSTEM CATHETER (Jun 7, 1993)
  • K925979 — DUAL LUMEN L-CATH CATHETER SYSTEM (May 27, 1993)
  • K924968 — L-CATH PEEL-AWAY CATHETER SYSTEM (May 21, 1993)

Other clearances for product code DQR

  • K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES (Oct 28, 2013)
  • K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA… (Jan 31, 2008)
  • K051655 — ANGIODYNAMICS, INC., MICRO ACCESS KITS (Sep 12, 2005)
  • K030398 — CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (May 23, 2003)
  • K960098 — RMI INTERNAL MAMMARY ARTERY CANNULA (Mar 26, 1996)
  • K902674 — DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (Jan 16, 1991)
  • K894784 — MODIFIED SHILEY FEMORAL VENOUS CANNULA (Mar 28, 1990)
  • K894243 — RMI ARTERIAL PERFUSION CANNULA (Sep 19, 1989)
  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K884478 — DAIG COLLAPSIBLE STERILE SLEEVE (Feb 22, 1989)

FDA data resources