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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 a medical device manufactured by Synaptic Medical Corporation. It received FDA 510(k) clearance on 2024-07-26 under approval 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. It is manufactured by Synaptic Medical Corporation. The 510(k) number is K240246.

When was Accusafe Transseptal Guidewire (GTR31180, GTR31230) approved by the FDA?

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

What company makes Accusafe Transseptal Guidewire (GTR31180, GTR31230)?

Accusafe Transseptal Guidewire (GTR31180, GTR31230) is manufactured by Synaptic Medical Corporation.

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

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

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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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