CardioCurve Steerable Sheath— 510(k) K210185

Name: FDA 510(k) clearance K210185
Creator: U.S. Food and Drug Administration
Published: 2021-07-23

Substantially Equivalent

Talon Surgical

FDA 510(k) clearance K210185 for CardioCurve Steerable Sheath, Substantially Equivalent on 2021-07-23. Applicant: Talon Surgical. Device class: 2.

Clearance details

Applicant: Talon Surgical
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2021-01-25
Decision date: 2021-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.