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510(k) K930012

KAWASUMI LABORATORIES K-CUFF by Kawasumi Laboratories Co., Ltd. — Product Code KZD

K930012 is an FDA 510(k) premarket notification submitted by Kawasumi Laboratories Co., Ltd. for the device "KAWASUMI LABORATORIES K-CUFF". The FDA issued a decision of Substantially Equivalent on December 14, 1993. The device falls under product code KZD (Infusor, Pressure, For I.V. Bags), a Class I device regulated under 21 CFR 880.5420. Kawasumi Laboratories Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1993
Date Received
January 4, 1993
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 Kawasumi Laboratories Co., Ltd.

  • K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET (March 8, 2000)
  • K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) (February 12, 1998)
  • K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (March 14, 1997)
  • K935514 — VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER (February 10, 1994)
  • K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER (February 3, 1994)
  • K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION (February 3, 1994)
  • K921901 — PORT ACCESS INFUSION SET (September 10, 1993)
  • K921902 — PORT ACCESS NEEDLE (July 28, 1993)
  • K923323 — INTERMITTENT INJECTION SITE (July 13, 1993)
  • K896893 — KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE (September 12, 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)
  • 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)
  • K904484 — BAXTER SINGLE PATIENT USE PRESSURE INFUSOR (October 26, 1990)

FDA data resources