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FDA 510(k)

Rapid Obstructive Hydrocephalus, Rapid OH

K-Number: K251533 · 2025-09-04

Decision Date2025-09-04
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid Obstructive Hydrocephalus, Rapid OH is a medical device manufactured by Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-09-04 under approval number K251533. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Obstructive Hydrocephalus, Rapid OH?

Rapid Obstructive Hydrocephalus, Rapid OH is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Ischemaview, Inc.. The 510(k) number is K251533.

When was Rapid Obstructive Hydrocephalus, Rapid OH approved by the FDA?

Rapid Obstructive Hydrocephalus, Rapid OH received FDA 510(k) clearance on 2025-09-04, under approval number K251533.

What company makes Rapid Obstructive Hydrocephalus, Rapid OH?

Rapid Obstructive Hydrocephalus, Rapid OH is manufactured by Ischemaview, Inc..

What is the FDA product code for Rapid Obstructive Hydrocephalus, Rapid OH?

The FDA product code for Rapid Obstructive Hydrocephalus, Rapid OH is QAS.

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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.