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FDA 510(k)

Socrates Aspiration System

K-Number: K223913 · 2023-09-20

ApplicantScientia Vascular, Inc.
Decision Date2023-09-20
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Socrates Aspiration System is a medical device manufactured by Scientia Vascular, Inc.. It received FDA 510(k) clearance on 2023-09-20 under approval number K223913. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Socrates Aspiration System?

Socrates Aspiration System is a medical device that received FDA 510(k) clearance on 2023-09-20. It is manufactured by Scientia Vascular, Inc.. The 510(k) number is K223913.

When was Socrates Aspiration System approved by the FDA?

Socrates Aspiration System received FDA 510(k) clearance on 2023-09-20, under approval number K223913.

What company makes Socrates Aspiration System?

Socrates Aspiration System is manufactured by Scientia Vascular, Inc..

What is the FDA product code for Socrates Aspiration System?

The FDA product code for Socrates Aspiration System is NRY.

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 NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES 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

Other Devices by Scientia Vascular, Inc.

K223560Plato 17 Microcatheter K231954Aristotle 18 Guidewire; Aristotle 24 Guidewire K222437Aristotle Colossus Guidewire K242301Socrates 38 Catheter K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

View all 7 devices →

Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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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