SHELHIGH NO-REACT VASCUPATCH— 510(k) K982810

Substantially Equivalent

Shelhigh, Inc.

FDA 510(k) clearance K982810 for SHELHIGH NO-REACT VASCUPATCH, Substantially Equivalent on 1998-10-28. Applicant: Shelhigh, Inc..

Clearance details

Applicant: Shelhigh, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1998-08-11
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millburn, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.