Instylla Microcatheter— 510(k) K191731

Substantially Equivalent

Instylla, Inc.

FDA 510(k) clearance K191731 for Instylla Microcatheter, Substantially Equivalent on 2019-08-13. Applicant: Instylla, Inc..

Clearance details

Applicant: Instylla, Inc.
Product code: Code KRA
Advisory panel: Cardiovascular
Date received: 2019-06-28
Decision date: 2019-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.