Patent Hemostasis Band (PH Band)— 510(k) K201695

Substantially Equivalent

Medical Ingenuities

FDA 510(k) clearance K201695 for Patent Hemostasis Band (PH Band), Substantially Equivalent on 2020-10-30. Applicant: Medical Ingenuities.

Clearance details

Applicant: Medical Ingenuities
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 2020-06-22
Decision date: 2020-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheaton, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.