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FDA 510(k)

Accusafe Transseptal Guidewire (GTR31180, GTR31230)

K-Number: K240246 · 2024-07-26

ApplicantSynaptic Medical Corporation
Decision Date2024-07-26
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Accusafe Transseptal Guidewire (GTR31180, GTR31230) is the device name listed in this FDA 510(k) record. The listed applicant is Synaptic Medical Corporation. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K240246. 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 Accusafe Transseptal Guidewire (GTR31180, GTR31230)?

Accusafe Transseptal Guidewire (GTR31180, GTR31230) is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Synaptic Medical Corporation. The 510(k) number is K240246.

When did Accusafe Transseptal Guidewire (GTR31180, GTR31230) receive FDA 510(k) clearance?

Accusafe Transseptal Guidewire (GTR31180, GTR31230) received FDA 510(k) clearance on 2024-07-26, under 510(k) number K240246.

Who is the listed applicant for Accusafe Transseptal Guidewire (GTR31180, GTR31230)?

The FDA 510(k) record lists Synaptic Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accusafe Transseptal Guidewire (GTR31180, GTR31230)?

The FDA product code for Accusafe Transseptal Guidewire (GTR31180, GTR31230) 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 Synaptic Medical Corporation 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.

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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.

K241042SafeSharp 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, LLCK172934Needle Free Transseptal CannulaPressure 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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