DRESSING CHANGE KIT— 510(k) K850887

Clearance details

Applicant

Creative Care Systems, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1985-03-04

Decision date

1985-05-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Maplewood, NJ, US

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K861406 — NON-KOR WINGED INFUSION SETS1986-05-06
• K852831 — NON-KOR ACCESS KITS1985-09-19
• K850888 — PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV1985-05-07
• K841742 — NON-CORING NEEDLE1984-07-06
• K840919 — DAYPAK SYS VII CATHETER CARE KIT1984-04-17

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →