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FDA 510(k)

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

K-Number: K253799 · 2026-03-13

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2026-03-13
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2026-03-13 under approval number K253799. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)?

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K253799.

When was SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) approved by the FDA?

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) received FDA 510(k) clearance on 2026-03-13, under approval number K253799.

What company makes SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)?

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) is manufactured by Pressure Products Medical Device Manufacturing, LLC.

What is the FDA product code for SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)?

The FDA product code for SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) is DXF.

Related Clinical Trials

NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

Other Devices by Pressure Products Medical Device Manufacturing, LLC

K172893SafeSept Needle Free Transseptal Guidewire K170671SafeSept Transseptal Guidewire K181031TSI Transseptal Introducer K172950TSN Transseptal Needle K172934Needle Free Transseptal Cannula K210328SafeSept Blunt Needle

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Related Devices (Code: DXF)

K182399Park Blade Septostomy CatheterCook Incorporated K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterEdwards Lifesciences, LLC K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. K242076VersaCross™ RF WireBaylis Medical Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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