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510(k) K910926

TECNADYNE SURGI-SQUEEZE INFUSION PUMP by Tecnadyne Scientific, Inc. — Product Code KZD

K910926 is an FDA 510(k) premarket notification submitted by Tecnadyne Scientific, Inc. for the device "TECNADYNE SURGI-SQUEEZE INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on August 2, 1991. 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
August 2, 1991
Date Received
March 5, 1991
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)
  • K912007 — BAXTER SINGLE PATIENT USE BLOOD PRESSURE CUFF (July 22, 1991)
  • K904484 — BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (October 26, 1990)

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)
  • K911216 — INFUSABLE (July 22, 1991)
  • K904484 — BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (October 26, 1990)

FDA data resources