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510(k) K974146

PARACENTESIS CATHETER DEVICE by Allegiance Healthcare Corp. — Product Code GCB

K974146 is an FDA 510(k) premarket notification submitted by Allegiance Healthcare Corp. for the device "PARACENTESIS CATHETER DEVICE". The FDA issued a decision of Substantially Equivalent on January 28, 1998. The device falls under product code GCB (Needle, Catheter), a Class I device regulated under 21 CFR 878.4200. Allegiance Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1998
Date Received
November 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Allegiance Healthcare Corp.

  • K023673 — AIRLIFE DEMAND NASAL CANNULA (May 2, 2003)
  • K023419 — TRILAMINATE DRAPES/TIBURON (February 11, 2003)
  • K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES (January 15, 2003)
  • K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN (January 9, 2003)
  • K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (December 18, 2002)
  • K023425 — DRAPES WITH ABSORBENT REINFORCEMENT (November 6, 2002)
  • K022765 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 11, 2002)
  • K023170 — NITRILE POWDER-FREE EXAMINATION GLOVES (October 9, 2002)
  • K023167 — BREATHABLE SURGICAL GOWN (October 2, 2002)
  • K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM (August 20, 2002)

Other clearances for product code GCB

  • K150800 — Valved Safety Centesis Catheter (November 12, 2015)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K923028 — TURKEL PNEUMOTHORAX KIT (August 4, 1992)
  • K900374 — ADAIR/VERESS NEEDLE INTRODUCER SET (April 20, 1990)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)

FDA data resources