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FDA 510(k)

Rubicon™ Control Support Catheter (H749394323506A1)

K-Number: K223633 · 2023-08-08

ApplicantBoston Scientific Corporation
Decision Date2023-08-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rubicon™ Control Support Catheter (H749394323506A1) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-08-08 under 510(k) number K223633. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rubicon™ Control Support Catheter (H749394323506A1)?

Rubicon™ Control Support Catheter (H749394323506A1) is a medical device that received FDA 510(k) clearance on 2023-08-08. The listed applicant is Boston Scientific Corporation. The 510(k) number is K223633.

When did Rubicon™ Control Support Catheter (H749394323506A1) receive FDA 510(k) clearance?

Rubicon™ Control Support Catheter (H749394323506A1) received FDA 510(k) clearance on 2023-08-08, under 510(k) number K223633.

Who is the listed applicant for Rubicon™ Control Support Catheter (H749394323506A1)?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rubicon™ Control Support Catheter (H749394323506A1)?

The FDA product code for Rubicon™ Control Support Catheter (H749394323506A1) is DQY.

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Related Devices (Code: DQY)

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.

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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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