Cleared Special

K221707 - SafeSept® Transseptal Guidewire (SS-140)

K221707 is an FDA 510(k) clearance for SafeSept Transseptal Guidewire (SS-140), manufactured by Pressure Products Medical Device Manufacturing, LLC. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Special 510(k) pathway after a 93-day FDA review.

K221707 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
93d
Days
Class 2
Risk

K221707 is an FDA 510(k) clearance for the SafeSept® Transseptal Guidewire (SS-140). 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 September 14, 2022 after a review of 93 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221707

510(k) Number K221707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2022
Decision Date September 14, 2022
Days to Decision 93 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
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

DRC Device Classification - Class 2, Special Controls

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 K221707.
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · Synaptic Medical Corporation · Jul 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · Pressure Products Medical Device Manufacturing, LLC · May 2024
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
K221707 · SafeSept® Transseptal Guidewire (SS-140)
Download PDF FDA Summary Pressure Products Med…