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FDA 510(k)

SafeSept Needle Free Transseptal Guidewire

K-Number: K172893 · 2017-12-21

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2017-12-21
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeSept Needle Free Transseptal Guidewire is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2017-12-21 under approval number K172893. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeSept Needle Free Transseptal Guidewire?

SafeSept Needle Free Transseptal Guidewire is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K172893.

When was SafeSept Needle Free Transseptal Guidewire approved by the FDA?

SafeSept Needle Free Transseptal Guidewire received FDA 510(k) clearance on 2017-12-21, under approval number K172893.

What company makes SafeSept Needle Free Transseptal Guidewire?

SafeSept Needle Free Transseptal Guidewire is manufactured by Pressure Products Medical Device Manufacturing, LLC.

What is the FDA product code for SafeSept Needle Free Transseptal Guidewire?

The FDA product code for SafeSept Needle Free Transseptal Guidewire is DRC.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING 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

K170671SafeSept Transseptal Guidewire K181031TSI Transseptal Introducer K172950TSN Transseptal Needle K172934Needle Free Transseptal Cannula K210328SafeSept Blunt Needle K221707SafeSept® Transseptal Guidewire (SS-140)

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Related Devices (Code: DRC)

K170671SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.

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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