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FDA 510(k)

ViaCath, AcQRate Dx Steerable Catheter

K-Number: K212593 · 2021-10-15

ApplicantBiotronick, Inc.
Decision Date2021-10-15
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ViaCath, AcQRate Dx Steerable Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biotronick, Inc.. It received FDA 510(k) clearance on 2021-10-15 under 510(k) number K212593. 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 ViaCath, AcQRate Dx Steerable Catheter?

ViaCath, AcQRate Dx Steerable Catheter is a medical device that received FDA 510(k) clearance on 2021-10-15. The listed applicant is Biotronick, Inc.. The 510(k) number is K212593.

When did ViaCath, AcQRate Dx Steerable Catheter receive FDA 510(k) clearance?

ViaCath, AcQRate Dx Steerable Catheter received FDA 510(k) clearance on 2021-10-15, under 510(k) number K212593.

Who is the listed applicant for ViaCath, AcQRate Dx Steerable Catheter?

The FDA 510(k) record lists Biotronick, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViaCath, AcQRate Dx Steerable Catheter?

The FDA product code for ViaCath, AcQRate Dx Steerable Catheter is DRF.

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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