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FDA 510(k)

Biotronik Stylets

K-Number: K191469 · 2019-08-01

ApplicantBiotronik, Inc.
Decision Date2019-08-01
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Biotronik Stylets is a medical device manufactured by Biotronik, Inc.. It received FDA 510(k) clearance on 2019-08-01 under approval number K191469. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biotronik Stylets?

Biotronik Stylets is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Biotronik, Inc.. The 510(k) number is K191469.

When was Biotronik Stylets approved by the FDA?

Biotronik Stylets received FDA 510(k) clearance on 2019-08-01, under approval number K191469.

What company makes Biotronik Stylets?

Biotronik Stylets is manufactured by Biotronik, Inc..

What is the FDA product code for Biotronik Stylets?

The FDA product code for Biotronik Stylets is DRB.

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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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