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FDA 510(k)

SmartClip Delivery Catheter (ADR-1715)

K-Number: K260565 · 2026-05-14

ApplicantElucent Medical
Decision Date2026-05-14
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SmartClip Delivery Catheter (ADR-1715) is a medical device manufactured by Elucent Medical. It received FDA 510(k) clearance on 2026-05-14 under approval number K260565. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartClip Delivery Catheter (ADR-1715)?

SmartClip Delivery Catheter (ADR-1715) is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by Elucent Medical. The 510(k) number is K260565.

When was SmartClip Delivery Catheter (ADR-1715) approved by the FDA?

SmartClip Delivery Catheter (ADR-1715) received FDA 510(k) clearance on 2026-05-14, under approval number K260565.

What company makes SmartClip Delivery Catheter (ADR-1715)?

SmartClip Delivery Catheter (ADR-1715) is manufactured by Elucent Medical.

What is the FDA product code for SmartClip Delivery Catheter (ADR-1715)?

The FDA product code for SmartClip Delivery Catheter (ADR-1715) is EOQ.

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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