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FDA 510(k)

CVAC Aspiration System + CVAC Image Processor

K-Number: K233472 · 2024-02-02

ApplicantCalyxo, Inc.
Decision Date2024-02-02
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CVAC Aspiration System + CVAC Image Processor is a medical device manufactured by Calyxo, Inc.. It received FDA 510(k) clearance on 2024-02-02 under approval number K233472. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVAC Aspiration System + CVAC Image Processor?

CVAC Aspiration System + CVAC Image Processor is a medical device that received FDA 510(k) clearance on 2024-02-02. It is manufactured by Calyxo, Inc.. The 510(k) number is K233472.

When was CVAC Aspiration System + CVAC Image Processor approved by the FDA?

CVAC Aspiration System + CVAC Image Processor received FDA 510(k) clearance on 2024-02-02, under approval number K233472.

What company makes CVAC Aspiration System + CVAC Image Processor?

CVAC Aspiration System + CVAC Image Processor is manufactured by Calyxo, Inc..

What is the FDA product code for CVAC Aspiration System + CVAC Image Processor?

The FDA product code for CVAC Aspiration System + CVAC Image Processor is FED.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT07033130 The Performance of Different Sound Paths in Adult NeuroZti CI-users TERMINATED NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING

Other Devices by Calyxo, Inc.

K260965CVAC Aspiration System K260013CVAC Image Processor

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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.

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