PERIPRO PATCH— 510(k) K052416

Substantially Equivalent

Hancock/Jaffe Laboratories

FDA 510(k) clearance K052416 for PERIPRO PATCH, Substantially Equivalent on 2005-10-25. Applicant: Hancock/Jaffe Laboratories.

Clearance details

Applicant: Hancock/Jaffe Laboratories
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2005-09-02
Decision date: 2005-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.