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510(k) K874618

BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER by Bentley Laboratories, Inc. — Product Code DQR

K874618 is an FDA 510(k) premarket notification submitted by Bentley Laboratories, Inc. for the device "BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on January 19, 1988. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Bentley Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
November 9, 1987
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 Bentley Laboratories, Inc.

  • K931967 — HE-30 GOLD (July 13, 1993)
  • K913956 — BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 (January 17, 1992)
  • K913692 — VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) (November 15, 1991)
  • K903641 — QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (November 9, 1990)
  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • K874867 — CATR(TM)-H CARDIOTOMY HOLDER (February 2, 1988)
  • K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (February 2, 1988)
  • K823273 — BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (January 5, 1983)
  • K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100 (January 5, 1983)
  • K823272 — VENOUS RESERVOIR BAG #BMR-1400 (December 30, 1982)

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