VSI StraitSet micro-introducer kit— 510(k) K161336

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K161336 for VSI StraitSet micro-introducer kit, Substantially Equivalent on 2016-08-11. Applicant: Vascular Solutions, Inc..

Clearance details

Applicant: Vascular Solutions, Inc.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2016-05-13
Decision date: 2016-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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.