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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 the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2017-12-21 under 510(k) 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. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K172893.

When did SafeSept Needle Free Transseptal Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for SafeSept Needle Free Transseptal Guidewire?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07515040Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- GuidanceRECRUITING

Other records listing Pressure Products Medical Device Manufacturing, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)K221707SafeSept® Transseptal Guidewire (SS-140)K210328SafeSept Blunt NeedleK181031TSI Transseptal IntroducerK172950TSN Transseptal Needle

View all 9 devices →

Related Devices (Code: DRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC

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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