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510(k) K904484

BAXTER SINGLE PATIENT USE PRESSURE INFUSOR by Tecnadyne Scientific, Inc. — Product Code KZD

K904484 is an FDA 510(k) premarket notification submitted by Tecnadyne Scientific, Inc. for the device "BAXTER SINGLE PATIENT USE PRESSURE INFUSOR". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Tecnadyne Scientific, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
October 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infusor, Pressure, For I.V. Bags
Device Class
Class I
Regulation Number
880.5420
Review Panel
HO
Submission Type

Other clearances by Tecnadyne Scientific, Inc.

  • K940431 — TECNADYNE 20/20 FOG INHIBITOR KIT (April 29, 1994)
  • K940891 — TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER (April 26, 1994)
  • K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP (August 2, 1991)
  • K912007 — BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF (July 22, 1991)

Other clearances for product code KZD

  • K974074 — INFUSION DYNAMICS POWER INFUSER (February 17, 1998)
  • K973843 — MSI PRESSURE INFUSOR (October 29, 1997)
  • K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (October 7, 1995)
  • K951988 — PRESSURIZER (June 14, 1995)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 1994)
  • K930012 — KAWASUMI LABORATORIES K-CUFF (December 14, 1993)
  • K921168 — ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (April 21, 1993)
  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K910926 — TECNADYNE SURGI-SQUEEZE INFUSION PUMP (August 2, 1991)
  • K911216 — INFUSABLE (July 22, 1991)

FDA data resources