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510(k) K862836

STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE by Shiley, Inc. — Product Code DXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1986
Date Received
July 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4310
Review Panel
CV
Submission Type

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  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

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  • K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (October 31, 1991)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K852232 — PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (August 9, 1985)
  • K842194 — PRESSURE MONITOR (August 27, 1984)
  • K831750 — PM-3 (July 26, 1983)
  • K822822 — GAMBRO PRESSURE MONITOR PRM 10 (October 18, 1982)
  • K820912 — PMS-2 PRESSURE MONITOR SEPARATOR (May 18, 1982)