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FDA 510(k)

SafeSept® Transseptal Guidewire (SS-140)

K-Number: K221707 · 2022-09-14

ApplicantPressure Products Medical Device Manufacturing, LLC
Decision Date2022-09-14
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SafeSept® Transseptal Guidewire (SS-140) is a medical device manufactured by Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2022-09-14 under approval number K221707. 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® Transseptal Guidewire (SS-140)?

SafeSept® Transseptal Guidewire (SS-140) is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K221707.

When was SafeSept® Transseptal Guidewire (SS-140) approved by the FDA?

SafeSept® Transseptal Guidewire (SS-140) received FDA 510(k) clearance on 2022-09-14, under approval number K221707.

What company makes SafeSept® Transseptal Guidewire (SS-140)?

SafeSept® Transseptal Guidewire (SS-140) is manufactured by Pressure Products Medical Device Manufacturing, LLC.

What is the FDA product code for SafeSept® Transseptal Guidewire (SS-140)?

The FDA product code for SafeSept® Transseptal Guidewire (SS-140) is DRC.

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: DRC)

K172893SafeSept Needle Free Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC 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 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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