Cleared Special

K253799 - SafeSept RF Transseptal Guidewire (SSRF132 (FDA 510(k) Clearance)

Also includes:
SSRF132R SSRF232 SSRF232R SSRF135 SSRF135R SSRF235 SSRF235R)

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

K253799 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular device
Download Printable Device Report (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.

View all Pressure Products Medical Device Manufacturing, LLC devices

Submission Details

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.

Device Classification

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 19
Devices cleared under the same product code (DXF) and FDA review panel - the closest regulatory comparables to K253799.
HOTWIRE RF GUIDEWIRE (901XXX)
K260292 · Atraverse Medical · Feb 2026
HOTWIRE RF GUIDEWIRE (901XXX)
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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
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)
K241414 · Circa Scientific, Inc. · Sep 2024