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510(k) K973546

KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code EZD

K973546 is an FDA 510(k) premarket notification submitted by Kendall Healthcare Products Co. Div.Of Tyco Health for the device "KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER". The FDA issued a decision of Substantially Equivalent on November 7, 1997. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. 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
November 7, 1997
Date Received
September 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
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)
  • 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)
  • K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE (July 31, 1996)

Other clearances for product code EZD

  • K261658 — LoFric Origo Pro Coudé (July 17, 2026)
  • K262045 — Luja Soft (July 7, 2026)
  • K260394 — Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NC (June 24, 2026)
  • K253295 — Coude Sleeved IC; Coude Plus Sleeved IC (May 18, 2026)
  • K260999 — LoFric Elle Pro (April 24, 2026)
  • K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air f (April 1, 2026)
  • K260502 — Liv Pre-lubricated Intermittent Catheter (March 12, 2026)
  • K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophil (January 29, 2026)
  • K251178 — Ready to use Nelaton Catheter (January 2, 2026)
  • K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (n (October 3, 2025)

FDA data resources