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

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..

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code DYB
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 ↗

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.