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510(k) K934782

AMMEX TUBING ORGANIZER by Ammex Cardiopulmonary Corp. — Product Code KRI

K934782 is an FDA 510(k) premarket notification submitted by Ammex Cardiopulmonary Corp. for the device "AMMEX TUBING ORGANIZER". The FDA issued a decision of Substantially Equivalent on November 18, 1993. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1993
Date Received
October 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

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  • K926233 — CARDIO2 CYCLE (June 4, 1993)
  • K922404 — TUBE GRIP (November 23, 1992)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)

FDA data resources