Cleared Traditional

Santreva?-ATK Endovascular Revasculariztion Catheter

K252315 · AngioSafe, Inc. · Cardiovascular

Sep 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K252315 is an FDA 510(k) clearance for the Santreva?-ATK Endovascular Revasculariztion Catheter, a Catheter For Crossing Total Occlusions (Class II — Special Controls, product code PDU), submitted by AngioSafe, Inc. (San Jose, US). The FDA issued a Cleared decision on September 22, 2025, 59 days after receiving the submission on July 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K252315 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2025
Decision Date	September 22, 2025
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PDU — Catheter For Crossing Total Occlusions
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.