Microcatheter— 510(k) K232647

Name: FDA 510(k) clearance K232647
Creator: U.S. Food and Drug Administration
Published: 2023-09-29

Substantially Equivalent

Surmodics,Inc.

FDA 510(k) clearance K232647 for Microcatheter, Substantially Equivalent on 2023-09-29. Applicant: Surmodics,Inc.. Device class: 2.

Clearance details

Applicant: Surmodics,Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2023-08-31
Decision date: 2023-09-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

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K231022 — Pounce Thrombectomy System2023-06-12
K221886 — Sublime Microcatheter2022-10-14

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.