Agile Devices Angler Steerable, Deflectable Microcatheter— 510(k) K211110

Name: FDA 510(k) clearance K211110
Creator: U.S. Food and Drug Administration
Published: 2022-01-07

Substantially Equivalent

Agile Devices, Inc.

FDA 510(k) clearance K211110 for Agile Devices Angler Steerable, Deflectable Microcatheter, Substantially Equivalent on 2022-01-07. Applicant: Agile Devices, Inc.. Device class: 2.

Clearance details

Applicant: Agile Devices, Inc.
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2021-04-14
Decision date: 2022-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wellesley, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRA

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K254051 — Extroducer Infusion Catheter System2026-09-11
K261610 — Verge Microcatheter2026-06-11
K260771 — TruSelect 2.6 Microcatheter2026-05-15
K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.