LimFlow ARC— 510(k) K221541

Substantially Equivalent

LimFlow, Inc.

FDA 510(k) clearance K221541 for LimFlow ARC, Substantially Equivalent on 2022-08-31. Applicant: LimFlow, Inc..

Clearance details

Applicant: LimFlow, Inc.
Product code: Code PDU
Advisory panel: Cardiovascular
Date received: 2022-05-27
Decision date: 2022-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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.