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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 the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2019-08-01 under 510(k) 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. The listed applicant is Biotronik, Inc.. The 510(k) number is K191469.

When did Biotronik Stylets receive FDA 510(k) clearance?

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

Who is the listed applicant for Biotronik Stylets?

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

What is the FDA product code for Biotronik Stylets?

The FDA product code for Biotronik Stylets is DRB.

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Related Devices (Code: DRB)

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.

K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)K182660GaltTWSGalt Medical Corp.K170298Liberator Beacon Tip Locking StyletCook Incorporated

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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