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510(k) K911324

IRRIGATION/ASPIRATION TUBING SET by Biomedical Dynamics, Inc. — Product Code KDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
March 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Biomedical Dynamics, Inc.

  • K915074 — IRRIGATOR/ASPIRATOR PROBE (February 5, 1992)
  • K913751 — PRESSURE INFUSER (January 9, 1992)
  • K911213 — CUFFABLE (August 7, 1991)
  • K911216 — INFUSABLE (July 22, 1991)
  • K904376 — ANEROID BLOOD PRESSURE GAUGE (December 20, 1990)
  • K890268 — PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION (May 5, 1989)
  • K881799 — BLOOD PRESSURE CUFF (October 14, 1988)
  • K861977 — BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR (July 15, 1986)
  • K850506 — CORRECT FLO INTRAVASCULAR ADMINISTRATION SET (April 1, 1985)

Other clearances for product code KDH

  • K983624 — GILTECH PLUS CONNECTING TUBE SET (March 18, 1999)
  • K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (June 19, 1998)
  • K971259 — COMBIPORT FLUID LAVAGE DEVICE (October 27, 1997)
  • K962850 — TUM-E-VAC (February 21, 1997)
  • K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT (July 5, 1995)
  • K923497 — FLUSHING IRRIGATION SET (March 21, 1994)
  • K920619 — TRI-MED GASTRIC LAVAGE SYSTEM (September 4, 1992)
  • K920527 — TRI-MED QUICK-STEP GASTRIC LAVAGE KIT (September 4, 1992)
  • K914908 — QUICVAGE PLUS (April 13, 1992)
  • K914907 — QUICVAGE (January 24, 1992)