PERCUSSIVETECH HF, MODEL 2001— 510(k) K981726

Substantially Equivalent

Vortran Medical Technology 1, Inc.

FDA 510(k) clearance K981726 for PERCUSSIVETECH HF, MODEL 2001, Substantially Equivalent on 1998-09-17. Applicant: Vortran Medical Technology 1, Inc..

Clearance details

Applicant: Vortran Medical Technology 1, Inc.
Product code: Code NHJ
Advisory panel: Anesthesiology
Date received: 1998-05-15
Decision date: 1998-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

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Adverse events under product code NHJ

product code NHJ

Death: 7
Total: 7

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.