FDA 510(k)

Tunnel Crossing Catheter

K-Number: K221163 · 2023-01-19

Decision Date2023-01-19

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Tunnel Crossing Catheter is a medical device manufactured by Tractus Vascular, LLC. It received FDA 510(k) clearance on 2023-01-19 under approval number K221163. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tunnel Crossing Catheter?

Tunnel Crossing Catheter is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Tractus Vascular, LLC. The 510(k) number is K221163.

When was Tunnel Crossing Catheter approved by the FDA?

Tunnel Crossing Catheter received FDA 510(k) clearance on 2023-01-19, under approval number K221163.

What company makes Tunnel Crossing Catheter?

Tunnel Crossing Catheter is manufactured by Tractus Vascular, LLC.

What is the FDA product code for Tunnel Crossing Catheter?

The FDA product code for Tunnel Crossing Catheter is PDU.

Other Devices by Tractus Vascular, LLC

K180889Tractus Crossing Support Catheter K183305Crossing Support Catheter

Related Devices (Code: PDU)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.