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510(k) K073559

18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II by Edwards Lifesciences Research Medical — Product Code DQR

K073559 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences Research Medical for the device "18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II". The FDA issued a decision of Substantially Equivalent on January 31, 2008. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Edwards Lifesciences Research Medical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2008
Date Received
December 19, 2007
Clearance Type
Special
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 Edwards Lifesciences Research Medical

  • K062429 — MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LA (September 27, 2006)
  • K990396 — T-ANASTAFLO (October 1, 1999)
  • K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (July 2, 1999)
  • K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA (June 11, 1999)
  • K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE (December 1, 1998)

Other clearances for product code DQR

  • K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES (October 28, 2013)
  • 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)
  • K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (January 11, 1989)

FDA data resources