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510(k) K951443

STANDARD FOLEY SYSTEM PAK by Trinity Laboratories, Inc. — Product Code FCN

K951443 is an FDA 510(k) premarket notification submitted by Trinity Laboratories, Inc. for the device "STANDARD FOLEY SYSTEM PAK". The FDA issued a decision of Substantially Equivalent on June 15, 1995. The device falls under product code FCN (Urinary Drainage Collection Kit, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Trinity Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1995
Date Received
March 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Drainage Collection Kit, For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Trinity Laboratories, Inc.

  • K981441 — HEART CATH TRAY, STERILE, DISPOSABLE (July 10, 1998)
  • K974238 — DENTAL TRAY, STERILE, DISPOSABLE (February 4, 1998)
  • K974286 — CIRCUMCISION TRAY, CAT. NO. 70340 (December 12, 1997)
  • K972160 — CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATIO (August 1, 1997)
  • K970722 — EYE TRAY (March 31, 1997)
  • K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (February 14, 1997)
  • K964921 — BASIC BIOPSY TRAY. DISPOSABLE, STERILE (January 22, 1997)
  • K953929 — MID-STREAM COLLECTION SET-STERILE (November 16, 1995)
  • K952058 — STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (September 21, 1995)
  • K953070 — WOUNDFOAM 4 X 4 (September 8, 1995)

Other clearances for product code FCN

  • K945258 — CATCO URINARY COLLECTION KIT (February 16, 1995)
  • K915166 — MICROCYCLER (September 7, 1994)
  • K922346 — FEMALE URINE SAMPLING DEVICE (August 14, 1992)
  • K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (July 14, 1989)
  • K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEM (December 19, 1988)
  • K883610 — LAKE FOLEY CATHETERIZATION TRAY (October 12, 1988)
  • K780134 — URINARY DRAINAGE MONITORING SYSTEM (February 2, 1978)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771210 — UROGARD URINARY DRAINAGE BAG (July 11, 1977)

FDA data resources