Cleared Special

K253799 - SafeSept RF Transseptal Guidewire (SSRF132

Also marketed or referenced as:
SSRF132R SSRF232 SSRF232R SSRF135 SSRF135R SSRF235 SSRF235R)

K253799 is an FDA 510(k) clearance for SafeSept RF Transseptal Guidewire (SSRF132, manufactured by Pressure Products Medical Device Manufacturing, LLC. The device is a Class 2 Cardiovascular device with product code DXF cleared through the Special 510(k) pathway after a 105-day FDA review.

K253799 · 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
Mar 2026
Decision
105d
Days
Class 2
Risk

K253799 is an FDA 510(k) clearance for the SafeSept RF Transseptal Guidewire (SSRF132. Classified as Catheter, Septostomy (product code DXF), Class II - Special Controls.

Submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on March 13, 2026 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - 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 - K253799

510(k) Number K253799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date March 13, 2026
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

DXF Device Classification - Class 2, Special Controls

Product Code DXF Catheter, Septostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
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 - DXF Catheter, Septostomy

All 20
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K253799.
LightningWire Transseptal Puncture System (TPS)
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K252419 · Atraverse Medical, Inc. · Aug 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
K251007 · Circa Scientific, Inc. · May 2025
Cross Wise™ Multi-Use RF Adapter Cable
K243193 · Circa Scientific, Inc. · Nov 2024
VersaCross™ RF Wire
K242076 · Baylis Medical Company · Nov 2024
K253799 · SafeSept RF Transseptal Guidewire (SSRF132
Download PDF FDA Summary Pressure Products Med…