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510(k) K884478

DAIG COLLAPSIBLE STERILE SLEEVE by Daig Corp. — Product Code DQR

K884478 is an FDA 510(k) premarket notification submitted by Daig Corp. for the device "DAIG COLLAPSIBLE STERILE SLEEVE". The FDA issued a decision of Substantially Equivalent on February 22, 1989. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Daig Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1989
Date Received
October 25, 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 Daig Corp.

  • K000004 — ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 (November 29, 2000)
  • K994334 — ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX (May 15, 2000)
  • K982299 — SPYGLASS 5 FR ANGIOGRAPHIC CATHETER (October 19, 1998)
  • K982187 — FAST-CATH INTRA-CARDIAC INTRODUCER (September 16, 1998)
  • K973840 — FAST-CATH (TM) INTRA-CARDIAC INTRODUCER (May 21, 1998)
  • K964518 — FAST-CATH TRANSSEPTAL CATHETER INTRODUCER (May 14, 1997)
  • K965249 — SPYGLASS ANGIOGRAPHIC CATHETER (February 21, 1997)
  • K962805 — SPYGLASS ANGIOGRAPHIC CATHETER (October 15, 1996)
  • K954317 — DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOP (November 28, 1995)
  • K944284 — CONTROL (March 3, 1995)

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)
  • K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (January 11, 1989)

FDA data resources