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510(k) K260051

Device
CorVision® (91-205-Z0014)
Applicant
CorVent® Medical, Inc.
510(k) number
K260051
Product code
MOD
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-12
Date received
2026-01-08
Regulation
868.5895
Classification name
Accessory To Continuous Ventilator (Respirator)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Richard Walsh
Address
4837 Amber Valley Pkwy. S Suite #2 Fargo ND US 58104 58104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MOD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242485EveryWareBreas Medical AB2025-05-20
K161411Care Cycle Connect ApplicationRespironics, Inc.2017-02-17
K091461BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUECardiopulmonary Corp.2009-08-14
K052751VENTLINK SYSTEMMediserve Information Systems, Inc.2005-12-23
K052244IISIS, VERSION 1.0Innovision Medical Technologies, LLC2005-10-13
K040712AIR SAFETY HEPA, MODEL 3500Air Safety, Ltd.2004-06-03
K022062IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00Impact Instrumentation, Inc.2003-05-06
K010401TRI-PLEX ADAPTERThe Medical Device Group, Inc.2002-10-30
K011861BERNOULLI VENTILATOR MANAGEMENT SYSTEMCardiopulmonary Corp.2001-11-06
K963633VENTNET; CENTRAL MONITORING STATIONPuritan Bennett Corp.1996-12-16
K935788BICORE SMARTCATH INTRATRACHEAL CATHETERBicore Monitoring Systems1995-07-03
K936156VENTILATION MECHANICS MONITOR MODEL VMM-100Smith Industries Medical Systems (Sims)1995-06-27
K940739NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTORNewport Medical Instruments, Inc.1995-03-07