Cleared Traditional

K252592 - TELLTALE Electrosurgical Guidewire System (FDA 510(k) Clearance)

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

K252592 · Telltale, LLC · Cardiovascular device
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Nov 2025
Decision
90d
Days
Class 2
Risk

K252592 is an FDA 510(k) clearance for the TELLTALE Electrosurgical Guidewire System. Classified as Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures (product code SGO), Class II - Special Controls.

Submitted by Telltale, LLC (Andover, US). The FDA issued a Cleared decision on November 13, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1254 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Telltale, LLC devices

Submission Details

510(k) Number K252592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2025
Decision Date November 13, 2025
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SGO Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1254
Definition The Device Is Intended For Electrosurgically Splitting Valve Leaflets To Facilitate A Planned Valvular Procedure
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
NCT05666713 Completed Interventional NIH-sponsored

NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

NHLBI Transmural Electrosurgery LeafLet Traversal and Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

90
Patients (actual)
10
Sites
Treatment
Purpose
Open label
Masking
Condition studied Valvular Heart Disease; Aortic Valve Failure
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator Robert J Lederman, M.D.
Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Started 2023-02-21 → Primary completion 2025-02-14 → Completed 2025-04-25
Primary outcome
Number of Participant That Experienced Technical Success With the TELLTALE Guidewire System
Secondary outcome
Freedom From Safety Events
View full study on ClinicalTrials.gov