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510(k) K113235

PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS by Medtronic, Inc. — Product Code DXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2011
Date Received
November 2, 2011
Clearance Type
Special
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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Other clearances for product code DXS

  • K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET (December 27, 1994)
  • 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)
  • K862836 — STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE (September 12, 1986)
  • 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)