LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM— 510(k) K111603

Substantially Equivalent

Ep Dynamics, Inc.

FDA 510(k) clearance K111603 for LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM, Substantially Equivalent on 2012-08-23. Applicant: Ep Dynamics, Inc..

Clearance details

Applicant: Ep Dynamics, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2011-06-08
Decision date: 2012-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mission Viejo, CA, US

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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.