PERCUSSIVETECH HF, MODEL 2001— 510(k) K981726

Name: FDA 510(k) clearance K981726
Creator: U.S. Food and Drug Administration
Published: 1998-09-17

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.. Device class: 2.

Clearance details

Applicant: Vortran Medical Technology 1, Inc.
Product code: Code NHJ
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 1998-05-15
Decision date: 1998-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHJ

view all

K260604 — BiWaze Clear System2026-08-24
K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)2026-06-16
K242438 — Clearo2025-05-16
K231728 — BiWaze Clear System2024-04-08
K213564 — BiWaze Clear System2022-12-21

More clearances from Vortran Medical Technology 1, Inc.

view all

K202219 — VORTRAN GO2VENT with PEEP Valve2021-02-11
K182292 — VORTRAN APM-Plus2019-09-18
K173914 — VORTRAN Cuff Inflator (VCI)2018-05-25
K162968 — VORTRAN GO2VENT2017-04-10
K153733 — VORTRAN Manometer2016-09-16

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.