FDA 510(k)

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

Numéro K : K233708 · 2024-02-16

Date de décision2024-02-16

Code produitDYB

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Synaptic Medical Corporation en tant que demandeur

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Dispositifs connexes (Code : DYB)

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Source officielle

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