ExpanSure Large Access Transseptal Dilator— 510(k) K201288

Substantially Equivalent

Baylis Medical Company, Inc.

FDA 510(k) clearance K201288 for ExpanSure Large Access Transseptal Dilator, Substantially Equivalent on 2020-06-12. Applicant: Baylis Medical Company, Inc..

Clearance details

Applicant: Baylis Medical Company, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2020-05-14
Decision date: 2020-06-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.