FDA 510(k)

VasoGuard (V10, V8, V6, V4, V2)

K-Number: K233976 · 2024-07-19

Decision Date2024-07-19

Product CodeJOP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VasoGuard (V10, V8, V6, V4, V2) is the device name listed in this FDA 510(k) record. The listed applicant is Corvascular Diagnostics, LLC. It received FDA 510(k) clearance on 2024-07-19 under 510(k) number K233976. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VasoGuard (V10, V8, V6, V4, V2)?

VasoGuard (V10, V8, V6, V4, V2) is a medical device that received FDA 510(k) clearance on 2024-07-19. The listed applicant is Corvascular Diagnostics, LLC. The 510(k) number is K233976.

When did VasoGuard (V10, V8, V6, V4, V2) receive FDA 510(k) clearance?

VasoGuard (V10, V8, V6, V4, V2) received FDA 510(k) clearance on 2024-07-19, under 510(k) number K233976.

Who is the listed applicant for VasoGuard (V10, V8, V6, V4, V2)?

The FDA 510(k) record lists Corvascular Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VasoGuard (V10, V8, V6, V4, V2)?

The FDA product code for VasoGuard (V10, V8, V6, V4, V2) is JOP.

Related Devices (Code: JOP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242662Falcon/Xpress (Falcon/Xpress)Viasonix , Ltd.K153762Smartdop XT6Koven Technology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.