PHILIPS ECG LEADWIRE SET— 510(k) K110287

Clearance details

Applicant

Philips Medical Systems

Product code

Code DSA

Device class

Class 2

Regulation

21 CFR 870.2900

Advisory panel

Cardiovascular

Date received

2011-01-31

Decision date

2011-02-15

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Andover, MA, US

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Death

2

Total

2

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 →

• Z-2495-2019 — Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configurationClass II·Terminated·Philips North America, LLC·20190719

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110287.