Home / 510(k) Clearances / K935774

510(k) K935774

CURITY FAST-CATH FEMALE CATHETER KIT by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code EYT

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 11, 1994
Date Received
December 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
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)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)

Other clearances for product code EYT

  • K934080 — URINARY DRAINAGE BAG (May 18, 1994)
  • K883057 — COMFORT CATH MALE EXTERNAL CATHETER (August 2, 1988)
  • K883119 — VPI NON-ADHESIVE CONDOM CATHETER (August 2, 1988)