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510(k) K934080

URINARY DRAINAGE BAG by Kit Pak, Inc. — Product Code EYT

K934080 is an FDA 510(k) premarket notification submitted by Kit Pak, Inc. for the device "URINARY DRAINAGE BAG". The FDA issued a decision of Substantially Equivalent on May 18, 1994. The device falls under product code EYT (Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile), a Class I device regulated under 21 CFR 876.5250. Kit Pak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1994
Date Received
August 20, 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 Kit Pak, Inc.

  • K942959 — KIT PAK WET SALINE DRESSING (February 14, 1995)
  • K941499 — KIT PAK DRESSING CHANGE TRAY (July 20, 1994)
  • K932310 — KIT PAK INCONTINENT SKIN CARE KIT (June 1, 1994)
  • K931013 — FOLEY CATHETER TRAY (August 9, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K924051 — KIT PAK I.V. START KIT (June 22, 1993)
  • K923906 — FOLEY INSERTION TRAY (June 22, 1993)
  • K922051 — KIT PAK'S FLUSHING KIT (June 17, 1993)
  • K925281 — KIT PAK URINARY CARE SUPPLIES (April 19, 1993)
  • K900148 — KIT PAK IRRIGATION TRAY (April 23, 1990)

Other clearances for product code EYT

  • K935774 — CURITY FAST-CATH FEMALE CATHETER KIT (April 11, 1994)
  • K883057 — COMFORT CATH MALE EXTERNAL CATHETER (August 2, 1988)
  • K883119 — VPI NON-ADHESIVE CONDOM CATHETER (August 2, 1988)

FDA data resources