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FDA 510(k)

RithmID-SD Steerable Diagnostic Electrophysiology Catheter

K-Number: K203793 · 2022-02-14

ApplicantSynaptic Medical Corporation
Decision Date2022-02-14
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RithmID-SD Steerable Diagnostic Electrophysiology Catheter 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 2022-02-14 under 510(k) number K203793. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter is a medical device that received FDA 510(k) clearance on 2022-02-14. The listed applicant is Synaptic Medical Corporation. The 510(k) number is K203793.

When did RithmID-SD Steerable Diagnostic Electrophysiology Catheter receive FDA 510(k) clearance?

RithmID-SD Steerable Diagnostic Electrophysiology Catheter received FDA 510(k) clearance on 2022-02-14, under 510(k) number K203793.

Who is the listed applicant for RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

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 RithmID-SD Steerable Diagnostic Electrophysiology Catheter?

The FDA product code for RithmID-SD Steerable Diagnostic Electrophysiology Catheter is DRF.

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)K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

Related Devices (Code: DRF)

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.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationPMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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