HEMO-BAND— 510(k) K920614

Substantially Equivalent

Innovations IN Access, Inc.

FDA 510(k) clearance K920614 for HEMO-BAND, Substantially Equivalent on 1992-07-27. Applicant: Innovations IN Access, Inc..

Clearance details

Applicant: Innovations IN Access, Inc.
Product code: Code KOC
Advisory panel: Gastroenterology, Urology
Date received: 1992-02-11
Decision date: 1992-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Linn, OR, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOC

product code KOC

Death: 4
Total: 4

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.