FDA 510(k)

Nitinol Enhanced Device (NED)

K-Number: K250276 · 2025-05-15

Decision Date2025-05-15

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Nitinol Enhanced Device (NED) is the device name listed in this FDA 510(k) record. The listed applicant is Embolization, Inc.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) 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. The listed applicant is Embolization, Inc.. The 510(k) number is K250276.

When did Nitinol Enhanced Device (NED) receive FDA 510(k) clearance?

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

Who is the listed applicant for Nitinol Enhanced Device (NED)?

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

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

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

Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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.