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FDA 510(k)

Rapid DeltaFuse

K-Number: K252526 · 2025-08-26

ApplicantIschemaview, Inc.
Decision Date2025-08-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid DeltaFuse is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-08-26 under approval number K252526. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid DeltaFuse?

Rapid DeltaFuse is a medical device that received FDA 510(k) clearance on 2025-08-26. It is manufactured by Ischemaview, Inc.. The 510(k) number is K252526.

When was Rapid DeltaFuse approved by the FDA?

Rapid DeltaFuse received FDA 510(k) clearance on 2025-08-26, under approval number K252526.

What company makes Rapid DeltaFuse?

Rapid DeltaFuse is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid DeltaFuse?

The FDA product code for Rapid DeltaFuse is LLZ.

Other Devices by Ischemaview, Inc.

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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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