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FDA 510(k)

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable

K-Number: K183632 · 2019-06-07

ApplicantBaylis Medical Company, Inc.
Decision Date2019-06-07
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2019-06-07 under approval number K183632. 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 Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable?

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K183632.

When was Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable approved by the FDA?

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable received FDA 510(k) clearance on 2019-06-07, under approval number K183632.

What company makes Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable?

Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable?

The FDA product code for Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable is DRF.

Related Clinical Trials

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Other Devices by Baylis Medical Company, Inc.

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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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