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510(k) K964519

CURITY THORACENTESIS TRAY by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code GCX

K964519 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "CURITY THORACENTESIS TRAY". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Kendall Healthcare Products Co. Div.Of Tyco Health has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
November 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

  • K973763 — KENDALL CURITY IODOFORM PACKING STRIP (December 31, 1997)
  • K973511 — KENDALL CURITY PETROLATUM GAUZE (December 16, 1997)
  • K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (December 15, 1997)
  • K973619 — KENDALL CURITY NON-ADHERING DRESSING (December 10, 1997)
  • K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (December 4, 1997)
  • K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (November 7, 1997)
  • K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING (April 23, 1997)
  • K963446 — KENDALL DUAL LUMEN CATHETER (March 18, 1997)
  • K964899 — KENDALL CURITY URETERAL CATHETER (February 7, 1997)
  • K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE (July 31, 1996)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)
  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)

FDA data resources