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SafeSept RF Transseptal Guidewire - SSRF135

by Pressure Products Medical Device Manufacturing, LLC

510(k) K253799

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253799↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK253799 Date13 Mar 2026ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXF
Models / Variants
SSRF135
Device Class
Class II
Regulation
21 CFR Part 870.5175
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SafeSept RF Transseptal Guidewire is a Catheter, Septostomy, designed for creating a transseptal puncture in cardiac procedures. It combines radiofrequency (RF) technology with a guidewire to facilitate controlled passage through the interatrial septum, aiding in procedures such as atrial septal defect closure or electrophysiology interventions.

This device is supplied sterile and intended for single-use, with models differentiated by size (e.g., SSRF132, SSRF235) and RF-enabled or non-RF variants (indicated by the ‘R’ suffix). It is classified as a Class II medical device under FDA regulations (21 CFR 870.5175) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. Compliance with the Medical Device Directive (MDD) is also noted.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of cardiac procedures is the SafeSept RF Transseptal Guidewire designed to assist with, and how does it differ from traditional guidewires?

    The SafeSept RF Transseptal Guidewire is specifically designed for creating a transseptal puncture during cardiac procedures such as atrial septal defect (ASD) closure or electrophysiology interventions. Unlike traditional guidewires, it combines radiofrequency (RF) technology to facilitate controlled passage through the interatrial septum, reducing the risk of complications during the procedure.

  • Are there different sizes or variants of the SafeSept RF Transseptal Guidewire, and how do I identify them?

    Yes, the SafeSept RF Transseptal Guidewire comes in multiple models differentiated by size (e.g., SSRF132, SSRF235) and whether they include RF technology (indicated by the ‘R’ suffix, such as SSRF132R). For example, SSRF132 and SSRF132R differ only in the presence of RF capability, while SSRF235 and SSRF235R represent a different size variant with or without RF.

  • Is the SafeSept RF Transseptal Guidewire intended for single-use or can it be reused?

    The SafeSept RF Transseptal Guidewire is explicitly supplied sterile and intended for single-use only. Reuse is not recommended or supported, as it could compromise sterility and device performance.

  • How should the SafeSept RF Transseptal Guidewire be stored, and what precautions should be taken?

    The device is supplied sterile, so it should be stored in its original packaging until use to maintain sterility. Store in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contamination, as this could compromise its integrity before use.

  • What regulatory pathways has the SafeSept RF Transseptal Guidewire followed, and how does this affect its use?

    The device has received FDA 510(k) clearance as substantially equivalent to a predicate device under the Medical Device Directive (MDD). It is classified as a Class II medical device (21 CFR 870.5175) and is intended for use in cardiovascular procedures. Compliance with these pathways ensures it meets established safety and performance standards for transseptal guidewires.