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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 the device name listed in this FDA 510(k) record. The listed applicant is Synaptic Medical Corporation. It received FDA 510(k) clearance on 2024-02-16 under 510(k) 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. The listed applicant is Synaptic Medical Corporation. The 510(k) number is K233708.

When did NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)?

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 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

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.

NCT06106594VOLT CE Mark StudyACTIVE_NOT_RECRUITINGNCT06223789VOLT-AF IDE Clinical StudyCOMPLETED

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.

K233900Nordica PV Cryo Mapping CatheterK240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)K203793RithmID-SD Steerable Diagnostic Electrophysiology Catheter

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, 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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