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FDA 510(k)

Nitinol Enhanced Device (NED)

K-Number: K250276 · 2025-05-15

ApplicantEmbolization, Inc.
Decision Date2025-05-15
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nitinol Enhanced Device (NED) is a medical device manufactured by Embolization, Inc.. It received FDA 510(k) clearance on 2025-05-15 under approval number K250276. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nitinol Enhanced Device (NED)?

Nitinol Enhanced Device (NED) is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by Embolization, Inc.. The 510(k) number is K250276.

When was Nitinol Enhanced Device (NED) approved by the FDA?

Nitinol Enhanced Device (NED) received FDA 510(k) clearance on 2025-05-15, under approval number K250276.

What company makes Nitinol Enhanced Device (NED)?

Nitinol Enhanced Device (NED) is manufactured by Embolization, Inc..

What is the FDA product code for Nitinol Enhanced Device (NED)?

The FDA product code for Nitinol Enhanced Device (NED) is KRD.

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39179152 Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment. Annales pharmaceutiques francaises (2025)

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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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