SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath— 510(k) K231227

Name: FDA 510(k) clearance K231227
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Substantially Equivalent

Baylis Medical Company, Inc.

FDA 510(k) clearance K231227 for SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath, Substantially Equivalent on 2023-12-20. Applicant: Baylis Medical Company, Inc.. Device class: 2.

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2023-04-28
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

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.