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510(k) K922404

TUBE GRIP by Georgia Medical Products, Inc. — Product Code KRI

K922404 is an FDA 510(k) premarket notification submitted by Georgia Medical Products, Inc. for the device "TUBE GRIP". The FDA issued a decision of Substantially Equivalent on November 23, 1992. 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 23, 1992
Date Received
May 21, 1992
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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  • K934782 — AMMEX TUBING ORGANIZER (November 18, 1993)
  • K926233 — CARDIO2 CYCLE (June 4, 1993)
  • 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