SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS— 510(k) K121504

Substantially Equivalent

Togo Medikit Co., Ltd.

FDA 510(k) clearance K121504 for SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS, Substantially Equivalent on 2012-09-27. Applicant: Togo Medikit Co., Ltd..

Clearance details

Applicant: Togo Medikit Co., Ltd.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2012-05-21
Decision date: 2012-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.