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FDA 510(k)

SINC Support Catheter

K-Number: K233350 · 2024-02-08

ApplicantReflow Medical, Inc.
Decision Date2024-02-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINC Support Catheter is a medical device manufactured by Reflow Medical, Inc.. It received FDA 510(k) clearance on 2024-02-08 under approval number K233350. 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 SINC Support Catheter?

SINC Support Catheter is a medical device that received FDA 510(k) clearance on 2024-02-08. It is manufactured by Reflow Medical, Inc.. The 510(k) number is K233350.

When was SINC Support Catheter approved by the FDA?

SINC Support Catheter received FDA 510(k) clearance on 2024-02-08, under approval number K233350.

What company makes SINC Support Catheter?

SINC Support Catheter is manufactured by Reflow Medical, Inc..

What is the FDA product code for SINC Support Catheter?

The FDA product code for SINC Support Catheter is DQY.

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Other Devices by Reflow Medical, Inc.

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Related Devices (Code: DQY)

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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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