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FDA 510(k)

CVAC Aspiration System

K-Number: K260965 · 2026-04-13

ApplicantCalyxo, Inc.
Decision Date2026-04-13
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CVAC Aspiration System is a medical device manufactured by Calyxo, Inc.. It received FDA 510(k) clearance on 2026-04-13 under approval number K260965. 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 Aspiration System is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Calyxo, Inc.. The 510(k) number is K260965.

When was CVAC Aspiration System approved by the FDA?

CVAC Aspiration System received FDA 510(k) clearance on 2026-04-13, under approval number K260965.

What company makes CVAC Aspiration System?

CVAC Aspiration System is manufactured by Calyxo, Inc..

What is the FDA product code for CVAC Aspiration System?

The FDA product code for CVAC Aspiration System is FED.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING 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 NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Calyxo, Inc.

K233472CVAC Aspiration System + CVAC Image Processor K260013CVAC Image Processor

Related Devices (Code: FED)

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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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