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510(k) K882977

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

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)

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  • 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)