Home / 510(k) Clearances / K880771

510(k) K880771

MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM by Medsurg Industries, Inc. — Product Code DQR

K880771 is an FDA 510(k) premarket notification submitted by Medsurg Industries, Inc. for the device "MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM". The FDA issued a decision of Substantially Equivalent on May 3, 1988. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Medsurg Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1988
Date Received
February 26, 1988
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

Other clearances by Medsurg Industries, Inc.

  • K920780 — MEDSURG INSERTION TRAY (August 19, 1994)
  • K940175 — MEDSURG STERILE O.R. TOWELS (May 26, 1994)
  • K934731 — MEDSURG STERILE IMAGING PRODUCTS (March 28, 1994)
  • K925558 — INFILTUBE (March 4, 1994)
  • K934971 — STERILE LAPAROTOMY SPONGES (February 7, 1994)
  • K920421 — MEDSURG MARSHMALLOW TRAY (December 13, 1993)
  • K920838 — MEDSURG CIRCUMCISION TRAY (October 15, 1993)
  • K931932 — DRESSING CHANGE TRAY-MODIFIED (August 27, 1993)
  • K914037 — MEDSURG O.R. PROCEDURE TRAY (June 22, 1993)
  • K914036 — MEDSURG LAPAROSCOPY TRAY (March 18, 1992)

Other clearances for product code DQR

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

FDA data resources