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510(k) K881977

PRESSURE INFUSOR by Primrose Medical, Inc. — Product Code KZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1988
Date Received
May 11, 1988
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 Primrose Medical, Inc.

  • K884715 — ACHELASIA BALLOON DIALATOR (September 29, 1989)
  • K884713 — COLONIC BALLOON DIALATORS (September 29, 1989)
  • K884714 — BILIARY DIALATOR (September 29, 1989)
  • K884711 — URETHRAL AND URETERAL BALLOON DILATATORS (September 29, 1989)
  • K884712 — ESOPHAGEAL AND PYLORIC BALLOON DIALATORS (September 8, 1989)
  • K884709 — ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) (September 8, 1989)
  • K883420 — LANCET, BLOOD (August 26, 1988)
  • K881976 — CATHETER, INTRAVASCULAR (August 4, 1988)
  • K881975 — SET, INTRAVASCULAR (July 29, 1988)
  • K881978 — ENTERAL FEEDING TUBES (July 13, 1988)

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)