BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208— 510(k) K122587

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K122587 for BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208, Substantially Equivalent on 2013-02-07. Applicant: St Jude Medical.

Clearance details

Applicant: St Jude Medical
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 2012-08-24
Decision date: 2013-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.