AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002— 510(k) K090867

Substantially Equivalent

Ep Dynamics, Inc.

FDA 510(k) clearance K090867 for AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002, Substantially Equivalent on 2009-07-30. Applicant: Ep Dynamics, Inc..

Clearance details

Applicant: Ep Dynamics, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2009-03-31
Decision date: 2009-07-30
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.