PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16— 510(k) K031948

Substantially Equivalent

Pm Devices, Inc.

FDA 510(k) clearance K031948 for PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16, Substantially Equivalent on 2003-09-16. Applicant: Pm Devices, Inc..

Clearance details

Applicant: Pm Devices, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 2003-06-24
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, Bc, CA

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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.