Cleared Traditional

K252315 - Santreva™-ATK Endovascular Revasculariztion Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K252315 · AngioSafe, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
59d
Days
Class 2
Risk

K252315 is an FDA 510(k) clearance for the Santreva™-ATK Endovascular Revasculariztion Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by AngioSafe, Inc. (San Jose, US). The FDA issued a Cleared decision on September 22, 2025 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all AngioSafe, Inc. devices

Submission Details

510(k) Number K252315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04663867 Completed Interventional Industry-sponsored

AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

Safety and Effectiveness Study of the AngioSafe Peripheral CTO Crossing System

79
Patients (actual)
18
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Artery Occlusion; Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Subhash Banerjee, MD
Sponsor AngioSafe, Inc. (industry)
Started 2021-02-03 → Primary completion 2023-04-25 → Completed 2023-06-15
Primary outcome
Clinical Success of AngioSafe Peripheral CTO Crossing System
Secondary outcome
Technical Success of AngioSafe Peripheral CTO Crossing System
View full study on ClinicalTrials.gov

Regulatory Peers - PDU Catheter For Crossing Total Occlusions

All 56
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K252315.
PowerWire® 14 Radiofrequency Guidewire Kit
K251158 · Baylis Medical Technologies, Inc. · Sep 2025
LimFlow ARC
K251376 · LimFlow, Inc. · May 2025
PowerWire Radiofrequency Guidewire Kit
K232562 · Baylis Medical Technologies, Inc. · Feb 2024
SoundBite® Crossing System XS Peripheral
K230159 · Soundbite Medical Solutions, Inc. · Aug 2023
Tigereye ST CTO-Crossing Catheter
K230594 · Avinger, Inc. · Apr 2023
Tunnel Crossing Catheter
K221163 · Tractus Vascular, LLC · Jan 2023