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510(k) K780267

CATH TRAY W/OUT CATHETER by Latex Ind., Inc. — Product Code EYZ

K780267 is an FDA 510(k) premarket notification submitted by Latex Ind., Inc. for the device "CATH TRAY W/OUT CATHETER". The FDA issued a decision of Substantially Equivalent on February 24, 1978. The device falls under product code EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Latex Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1978
Date Received
February 17, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Latex Ind., Inc.

  • K812058 — AKRON URINARY DRAINAGE BAT (July 31, 1981)
  • K810281 — UROLOGICAL CATHETERS (February 25, 1981)
  • K791674 — BLADDER RETENTION CATHETERIZATION TRAY (November 5, 1979)
  • K781751 — CATHETER, AKRON FOLEY TEFLON (January 22, 1979)
  • K781433 — AKRON MALE EXTERNAL CATHETER (November 3, 1978)
  • K772277 — BLADDER RETENTION-CATHETHERIZATIONTRAY (March 2, 1978)
  • K772341 — BLADDER KIT - 734000 (February 24, 1978)
  • K772342 — ROBINSON KIT - 750014 & 750016 (February 24, 1978)
  • K772340 — CATHETERIZATION KIT 732016-732018 (February 24, 1978)
  • K780268 — BLADDER CATH KIT W/OUT CATHETER (February 24, 1978)

Other clearances for product code EYZ

  • K964219 — ZIP CONDOM CATHETER (August 11, 1997)
  • K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10 (November 19, 1996)
  • K952780 — URINARY GEL DRAINAGE SYSTEM (December 12, 1995)
  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)
  • K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (November 2, 1994)
  • K933126 — COMFORTCARE SYSTEM (February 25, 1994)
  • K930556 — NIGHT URINARY DRAINAGE BEDSIDE BAG (May 14, 1993)
  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K890465 — CLOSED SYSTEM URINARY DRAINAGE BAG (May 23, 1989)

FDA data resources