SOLOPICC 24 (60CM) 20GA CATHETER— 510(k) K954428

Clearance details

Applicant

Douglas Medical Products Corp.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1995-09-22

Decision date

1996-03-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Libertyville, IL, US

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• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K961155 — SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 719081996-06-18
• K941628 — 40 MICRON BLOOD TRANSFUSION FILTER1995-02-16
• K942101 — 4-LEAD IRRIGATION SET1994-09-30
• K941453 — CHECK VALVE SOLUTION SET1994-08-16
• K930854 — SOLUTION SET WITH .2 MICRON FILTER1994-01-14

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 →