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FDA 510(k)

Disposable Balloon Catheter B5-2C

K-Number: K250118 · 2025-06-04

ApplicantOlympus Medical Systems Corporation
Decision Date2025-06-04
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Disposable Balloon Catheter B5-2C is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-06-04 under approval number K250118. 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 Disposable Balloon Catheter B5-2C?

Disposable Balloon Catheter B5-2C is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K250118.

When was Disposable Balloon Catheter B5-2C approved by the FDA?

Disposable Balloon Catheter B5-2C received FDA 510(k) clearance on 2025-06-04, under approval number K250118.

What company makes Disposable Balloon Catheter B5-2C?

Disposable Balloon Catheter B5-2C is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for Disposable Balloon Catheter B5-2C?

The FDA product code for Disposable Balloon Catheter B5-2C is EOQ.

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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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