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510(k) K882977

ASK-300 by Medical Repackers Co. — Product Code DQR

K882977 is an FDA 510(k) premarket notification submitted by Medical Repackers Co. for the device "ASK-300". The FDA issued a decision of Substantially Equivalent on January 5, 1989. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. Medical Repackers Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1989
Date Received
July 15, 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 Medical Repackers Co.

  • K890575 — ACCUTHERM PTS-200 (May 5, 1989)
  • K881313 — IQK-200 (May 19, 1988)
  • K881429 — YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH. (April 25, 1988)
  • K874674 — AIK-100 ANESTHESIA INDUCTION KIT/TRAY (March 2, 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)
  • K884628 — HARBORIN CENTRAL VENOUS CATHETER (May 15, 1989)
  • K884478 — DAIG COLLAPSIBLE STERILE SLEEVE (February 22, 1989)

FDA data resources