Cleared Special

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (K241042) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241042 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
30d
Days
Class 2
Risk

K241042 is an FDA 510(k) clearance for the SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198). Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on May 17, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pressure Products Medical Device Manufacturing, LLC devices

Submission Details

510(k) Number K241042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2024
Decision Date May 17, 2024
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 Peers - DRC Trocar

All 50
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K241042.
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · Synaptic Medical Corporation · Jul 2024
SafeSept® Transseptal Guidewire (SS-140)
K221707 · Pressure Products Medical Device Manufacturing, LLC · Sep 2022
PathBuilder Transseptal Needle
K212625 · Shanghai Microport EP Medtech Co., Ltd. · Mar 2022
SafeSept Blunt Needle
K210328 · Pressure Products Medical Device Manufacturing, LLC · Mar 2021
TSN Transseptal Needle
K172950 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018
Needle Free Transseptal Cannula
K172934 · Pressure Products Medical Device Manufacturing, LLC · Feb 2018