FDA 510(k)

Selectra 3D Outer Guiding Catheters

K-Number: K193474 · 2020-10-16

Decision Date2020-10-16

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Selectra 3D Outer Guiding Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K193474. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Selectra 3D Outer Guiding Catheters?

Selectra 3D Outer Guiding Catheters is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Biotronik, Inc.. The 510(k) number is K193474.

When did Selectra 3D Outer Guiding Catheters receive FDA 510(k) clearance?

Selectra 3D Outer Guiding Catheters received FDA 510(k) clearance on 2020-10-16, under 510(k) number K193474.

Who is the listed applicant for Selectra 3D Outer Guiding Catheters?

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 Selectra 3D Outer Guiding Catheters?

The FDA product code for Selectra 3D Outer Guiding Catheters is DQY.

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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.