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510(k) K910599

CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR by Jtl Medical Corp. — Product Code DTW

K910599 is an FDA 510(k) premarket notification submitted by Jtl Medical Corp. for the device "CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR". The FDA issued a decision of Substantially Equivalent on May 20, 1993. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. Jtl Medical Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1993
Date Received
February 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type

Other clearances by Jtl Medical Corp.

  • K905818 — VACUUM-ASSISTED BLOOD COLLECTION SYSTEM (June 6, 1991)
  • K910021 — CARDIOPULMONARY BYPASS PUMP TUBING (May 22, 1991)

Other clearances for product code DTW

  • K150530 — Level Sensor, Level Sensor Tape (May 8, 2015)
  • K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM (July 2, 2004)
  • K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (November 10, 1999)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K915337 — CAPIOX LEVEL ALARM (February 21, 1992)
  • K900910 — COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (May 22, 1990)
  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)
  • K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (May 30, 1986)

FDA data resources