TORFLEX TRANSSEPTAL GUIDING SHEATH— 510(k) K102948

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K102948 for TORFLEX TRANSSEPTAL GUIDING SHEATH, Substantially Equivalent on 2011-04-01. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2010-10-05
Decision date: 2011-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, 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.