Sheath Introducer— 510(k) K150932

Substantially Equivalent

Bioteque Corp.

FDA 510(k) clearance K150932 for Sheath Introducer, Substantially Equivalent on 2016-07-22. Applicant: Bioteque Corp..

Clearance details

Applicant: Bioteque Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2015-04-06
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.