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FDA 510(k)

Nordica PV Cryo Mapping Catheter

K-Number: K233900 · 2024-09-06

ApplicantSynaptic Medical Corporation
Decision Date2024-09-06
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nordica PV Cryo Mapping 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 2024-09-06 under 510(k) number K233900. 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 Nordica PV Cryo Mapping Catheter?

Nordica PV Cryo Mapping Catheter is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Synaptic Medical Corporation. The 510(k) number is K233900.

When did Nordica PV Cryo Mapping Catheter receive FDA 510(k) clearance?

Nordica PV Cryo Mapping Catheter received FDA 510(k) clearance on 2024-09-06, under 510(k) number K233900.

Who is the listed applicant for Nordica PV Cryo Mapping 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 Nordica PV Cryo Mapping Catheter?

The FDA product code for Nordica PV Cryo Mapping 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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)K233708NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)K203793RithmID-SD Steerable Diagnostic Electrophysiology Catheter

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 CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

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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