ARMADA 35/35LL PTA CATHETER— 510(k) K111899

Clearance details

Applicant

Abbott Vascular

Product code

Code LIT

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2011-07-05

Decision date

2011-10-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Santa Clara, CA, US

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Death

27

Injury

1,256

Malfunction

12,127

Total

13,410

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-2450-2012 — Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.Class II·Terminated·Abbott Vascular·20120820

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111899.