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510(k) K884628

HARBORIN CENTRAL VENOUS CATHETER by Harbor Medical Devices, Inc. — Product Code DQR

K884628 is an FDA 510(k) premarket notification submitted by Harbor Medical Devices, Inc. for the device "HARBORIN CENTRAL VENOUS CATHETER". The FDA issued a decision of Substantially Equivalent on May 15, 1989. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Harbor Medical Devices, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1989
Date Received
November 7, 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 Harbor Medical Devices, Inc.

  • K890518 — SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM (April 21, 1989)
  • K882657 — HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT (December 13, 1988)
  • K881884 — HARBOR CENTRAL VENOUS CATHETER (July 28, 1988)
  • K882190 — S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM (June 9, 1988)
  • K880297 — SEA - PORT INFUSION SET (February 19, 1988)
  • K874414 — HYPODERMIC NEEDLES, SINGLE LUMEN (January 14, 1988)

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)
  • K884478 — DAIG COLLAPSIBLE STERILE SLEEVE (February 22, 1989)
  • K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (January 11, 1989)

FDA data resources