CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY— 510(k) K945521

Clearance details

Applicant

Menlo Care, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1994-11-10

Decision date

1995-04-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Menlo Park, CA, US

• K260432 — Ruby Intravascular Catheter2026-09-02
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• 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

• K964447 — PICC CATHETER/MIDLINE CATHETER1997-04-16
• K951620 — MIDMARK MIDLINE CATHETER1996-04-04
• K944968 — LANDMARK MIDLINE CATHETER1995-03-29
• K950737 — LANDMARK MIDLINE CATHETER1995-03-29
• K943893 — PERCUTANEOUS GRAINAGE CATHETER1995-03-07

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 →