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FDA 510(k)

Opticross 35 15 MHz Peripheral Imaging Catheter

K-Number: K200733 · 2020-04-17

ApplicantBoston Scientific Corporation
Decision Date2020-04-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Opticross 35 15 MHz Peripheral Imaging Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-04-17 under approval number K200733. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Opticross 35 15 MHz Peripheral Imaging Catheter?

Opticross 35 15 MHz Peripheral Imaging Catheter is a medical device that received FDA 510(k) clearance on 2020-04-17. It is manufactured by Boston Scientific Corporation. The 510(k) number is K200733.

When was Opticross 35 15 MHz Peripheral Imaging Catheter approved by the FDA?

Opticross 35 15 MHz Peripheral Imaging Catheter received FDA 510(k) clearance on 2020-04-17, under approval number K200733.

What company makes Opticross 35 15 MHz Peripheral Imaging Catheter?

Opticross 35 15 MHz Peripheral Imaging Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for Opticross 35 15 MHz Peripheral Imaging Catheter?

The FDA product code for Opticross 35 15 MHz Peripheral Imaging Catheter is ITX.

Related Clinical Trials

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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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