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FDA 510(k)

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

K-Number: K233708 · 2024-02-16

ApplicantSynaptic Medical Corporation
Decision Date2024-02-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is a medical device manufactured by Synaptic Medical Corporation. It received FDA 510(k) clearance on 2024-02-16 under approval number K233708. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is a medical device that received FDA 510(k) clearance on 2024-02-16. It is manufactured by Synaptic Medical Corporation. The 510(k) number is K233708.

When was NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) approved by the FDA?

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) received FDA 510(k) clearance on 2024-02-16, under approval number K233708.

What company makes NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is manufactured by Synaptic Medical Corporation.

What is the FDA product code for NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

The FDA product code for NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is DYB.

Related Clinical Trials

NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT07531368 BBAP With CS Mapping Guidance NOT_YET_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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