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510(k) K820912

PMS-2 PRESSURE MONITOR SEPARATOR by Delta Medical Industries — Product Code DXS

K820912 is an FDA 510(k) premarket notification submitted by Delta Medical Industries for the device "PMS-2 PRESSURE MONITOR SEPARATOR". The FDA issued a decision of Substantially Equivalent on May 18, 1982. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. Delta Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1982
Date Received
April 1, 1982
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

Other clearances by Delta Medical Industries

  • K833884 — ISOTEC DISPOS. PRESSURE TRANSDUCER (April 17, 1984)
  • K840253 — ONE-WAY AIR VALVE (April 5, 1984)
  • K832470 — INFUSION PUMP (February 28, 1984)
  • K830389 — ACCU-RYNGE PUMP SP-250 (September 12, 1983)
  • K831750 — PM-3 (July 26, 1983)
  • K822761 — DELIVERY TUBE SET #2226 (September 30, 1982)
  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K810068 — PEDIATRIC ARTERIAL BLOOD FILTER (January 22, 1981)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)
  • K803102 — ARTERIAL BUBBLE TRAP K-20 (December 22, 1980)

Other clearances for product code DXS

  • K113235 — PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (December 2, 2011)
  • 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)

FDA data resources