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FDA 510(k)

Santreva™-ATK Endovascular Revasculariztion Catheter

K-Number: K252315 · 2025-09-22

ApplicantAngioSafe, Inc.
Decision Date2025-09-22
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Santreva™-ATK Endovascular Revasculariztion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is AngioSafe, Inc.. It received FDA 510(k) clearance on 2025-09-22 under 510(k) 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. The listed applicant is AngioSafe, Inc.. The 510(k) number is K252315.

When did Santreva™-ATK Endovascular Revasculariztion Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Santreva™-ATK Endovascular Revasculariztion Catheter?

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

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 Devices (Code: PDU)

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.

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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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