Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
Dental · 21 CFR 872.5570
Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
Recent MDR events
4 adverse event reports on file
- PROVENT SLEEP THERAPYMay 1, 2017MalfunctionProvent Sleep Therapy, Llc3011683122-2017-00001
- PROVENT SLEEP APNEA THERAPYNov 23, 2016MalfunctionProvent Sleep TherapyMW5066350
- PROVENTApr 7, 2013MalfunctionVentus MedicalMW5029692
- PROVENT PROFESSIONAL SLEEP APNEA THERAPYOct 24, 2012InjuryVentus Medical3007038487-2012-00001
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Ventus Medical, Inc.TerminatedFeb 15, 2012
Provent -SR - Sleep Apnea Therapy-SR (standard resistance).
A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
Z-1033-2012 · View FDA record ↗ - American Contract SystemsTerminatedUnknown
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Z-2175-2020 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Bryggs Medical, LLCFeb 21, 2020
K191728 · ULTepap Expiratory Positive Airway Pressure (EPAP) Device
- Innomed Healthscience, Inc.Aug 16, 2018
K180619 · Bongo
- Ventus Medical, Inc.Dec 2, 2010
K102404 · PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
- Ventus Medical, Inc.Apr 3, 2009
K090398 · PROVENT PROFESSIONAL SLEEP APNEA THERAPY
- Ventus Medical, Inc.Feb 8, 2008
K071560 · PROVENT NASAL DILATOR, MODEL BR2