Cleared Traditional

K181088 - TSP Crosser Transseptal Access System

K181088 is the FDA 510(k) clearance for TSP Crosser Transseptal Access System by Transseptal Solutions , Ltd.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K181088 · Transseptal Solutions , Ltd. · Cardiovascular device
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Sep 2018
Decision
156d
Days
Class 2
Risk

K181088 is an FDA 510(k) clearance for the TSP Crosser Transseptal Access System. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Transseptal Solutions , Ltd. (Natanya, IL). The FDA issued a Cleared decision on September 28, 2018 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Transseptal Solutions , Ltd. devices

Submission Details

510(k) Number K181088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2018
Decision Date September 28, 2018
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Boston Biomedical Associates
Mary P. LeGraw

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K181088.
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