Lim Precision Steerable TS, Steerable Sheath, Dilator— 510(k) K202226

Name: FDA 510(k) clearance K202226
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Substantially Equivalent

Keystone Heart, Ltd.

FDA 510(k) clearance K202226 for Lim Precision Steerable TS, Steerable Sheath, Dilator, Substantially Equivalent on 2020-12-15. Applicant: Keystone Heart, Ltd.. Device class: 2.

Clearance details

Applicant: Keystone Heart, Ltd.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2020-08-07
Decision date: 2020-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesaria, IL

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.