510(k) clearances

Valence InVent Xtend™ (CVG-4101-VXA)

Convergence Medical Sciences , Ltd. · Anesthesiology

K253807Substantially EquivalentTraditionalMOD
Open FDA's page for this record
Third party flag
N
City
Calgary
Advisory committee description
Anesthesiology
Address 1
4121 23b St. NE
Statement or summary
Summary
Product code
MOD
Zip code
T2E 7V9
Applicant
Convergence Medical Sciences , Ltd.
Decision date
2026-08-20
Decision code
SESE
Country code
CA
Device name
Valence InVent Xtend™ (CVG-4101-VXA)
Advisory committee
AN
Contact
Marvin Cervantes
K number
K253807
Date received
2025-11-28
Review advisory committee
AN
Postal code
T2E 7V9
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Accessory To Continuous Ventilator (Respirator)
Medical specialty description
Anesthesiology
Regulation number
868.5895
Device class
2
Registration number
3033571078, 3005855942, 3010817335, 2024500, 2028807, 9617566, 9710644, 3004428458
FEI number
3033571078, 3005855942, 3010817335, 2024500, 3003949221, 3004428458, 1000374126, 3003244771
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.