Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033571078

FEI Number

3033571078

Entity Name

CORVENT MEDICAL INC.

City/State/Country

Fargo, ND, US

Establishment Address

4837 Amber Valley Parkway S, Suite #2, Fargo, ND 58104, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CorVent Medical Inc. (Owner Number: 10092028)

Owner / Operator Contact Address

4837 Amber Valley Parkway S, Suite #2, Fargo, ND 58104, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241135

PMA Number

N/A

All Registered Proprietary Names

CorVision RESPOND Ventilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MOD	Accessory To Continuous Ventilator (Respirator)	Anesthesiology	Class 2	868.5895	2026-05-15
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CorVent Medical Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033571078. Last updated year: 2026. Please use registration number 3033571078 when referencing this establishment in official correspondence.