Cleared Special

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)

K253799 · Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Mar 2026
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K253799 is an FDA 510(k) clearance for the SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R), a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on March 13, 2026, 105 days after receiving the submission on November 28, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K253799 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DXF — Catheter, Septostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5175

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