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510(k) K860084

PRESSURE INFUSOR #1900 by Pa Medical Corp. — Product Code KZD

K860084 is an FDA 510(k) premarket notification submitted by Pa Medical Corp. for the device "PRESSURE INFUSOR #1900". The FDA issued a decision of Substantially Equivalent on March 18, 1986. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Pa Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1986
Date Received
January 9, 1986
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 Pa Medical Corp.

  • K910903 — INFLATE-A-CUFF #7014 (May 8, 1991)
  • K871449 — ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG (June 17, 1987)
  • K854595 — P.A. MEDICAL VAGINAL IRRIGATION SET #1130 (January 13, 1986)
  • K853309 — P.A. ENTERAL FEEDING BAG 1100 (August 27, 1985)

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