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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 a medical device manufactured by Biotronick, Inc.. It received FDA 510(k) clearance on 2021-10-15 under approval 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. It is manufactured by Biotronick, Inc.. The 510(k) number is K212593.

When was ViaCath, AcQRate Dx Steerable Catheter approved by the FDA?

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

What company makes ViaCath, AcQRate Dx Steerable Catheter?

ViaCath, AcQRate Dx Steerable Catheter is manufactured by Biotronick, Inc..

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

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

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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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