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510(k) K912045

TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST by Lifestream Int'L, Inc. — Product Code DXS

K912045 is an FDA 510(k) premarket notification submitted by Lifestream Int'L, Inc. for the device "TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST". The FDA issued a decision of Substantially Equivalent on October 31, 1991. The device falls under product code DXS (Gauge, Pressure, Coronary, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4310. Lifestream Int'L, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
May 8, 1991
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 Lifestream Int'L, Inc.

  • K964571 — VISION CARDIOPLEGIA DELIVERY SYSTEM (August 8, 1997)
  • K962354 — DIOMED 15, 30, 60 SURGICAL DIODE LASER (September 11, 1996)
  • K920178 — CARDIOTOMY RESERVOIR W/20 MICRON FILITER (May 13, 1993)
  • K920618 — AUTOTRANSFUSION SUCTION SET (March 12, 1993)
  • K913181 — AUTOLOGOUS BLOOD PROCESSING SYSTEM (May 20, 1992)
  • K914396 — SURGI LIGHT NON-CONTACT FIBERS (December 23, 1991)
  • K911523 — MODIFICATION TO MODEL 90-1460 LASER ADAPTER (April 22, 1991)
  • K910726 — LIGHT-TOUCH AND SURGI LIGHT FIBERS (March 29, 1991)
  • K904491 — TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 (February 1, 1991)
  • K903709 — SURGIMEDICS, SLP LAPAROSCOPIC CHOLANGIOGRAM CATH (October 26, 1990)

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)
  • 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)

FDA data resources