FDA 510(k)

Santreva-ATK Endovascular Revasculariztion Catheter

K-Number: K252315 · 2025-09-22

Decision Date2025-09-22

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Santreva-ATK Endovascular Revasculariztion Catheter is a medical device manufactured by AngioSafe, Inc.. It received FDA 510(k) clearance on 2025-09-22 under approval number K252315. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Santreva-ATK Endovascular Revasculariztion Catheter?

Santreva-ATK Endovascular Revasculariztion Catheter is a medical device that received FDA 510(k) clearance on 2025-09-22. It is manufactured by AngioSafe, Inc.. The 510(k) number is K252315.

When was Santreva-ATK Endovascular Revasculariztion Catheter approved by the FDA?

Santreva-ATK Endovascular Revasculariztion Catheter received FDA 510(k) clearance on 2025-09-22, under approval number K252315.

What company makes Santreva-ATK Endovascular Revasculariztion Catheter?

Santreva-ATK Endovascular Revasculariztion Catheter is manufactured by AngioSafe, Inc..

What is the FDA product code for Santreva-ATK Endovascular Revasculariztion Catheter?

The FDA product code for Santreva-ATK Endovascular Revasculariztion Catheter is PDU.

Related Clinical Trials

NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT06588543 Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping RECRUITING NCT04790370 Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism ACTIVE_NOT_RECRUITING NCT07542938 Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis NOT_YET_RECRUITING

Related Devices (Code: PDU)

K162418Pioneer Plus CatheterPhilips Volcano K161208CROSSER CTO Recanalization CatheterBard Peripheral Vacular, Inc. K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc K183357XableCath Crossing CatheterXablecath, Inc. K201330Tigereye CTO-Crossing CatheterAvinger, Inc. K192211SoundBite Console, SoundBite Active Wire 18Soundbite Medical Solution, 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.