NRG TRANSSEPTAL NEEDLE— 510(k) K073326

Substantially Equivalent

Baylis Medical Co., Inc.

FDA 510(k) clearance K073326 for NRG TRANSSEPTAL NEEDLE, Substantially Equivalent on 2008-05-28. Applicant: Baylis Medical Co., Inc..

Clearance details

Applicant: Baylis Medical Co., Inc.
Product code: Code DXF
Advisory panel: Cardiovascular
Date received: 2007-11-27
Decision date: 2008-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

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Adverse events under product code DXF

product code DXF

Death: 78
Injury: 1,126
Malfunction: 507
Other: 1
Total: 1,712

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.