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FDA 510(k)

SSPC NXT Delivery Catheter

K-Number: K243180 · 2024-12-04

ApplicantCenterPoint Systems, LLC
Decision Date2024-12-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SSPC NXT Delivery Catheter is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2024-12-04 under approval number K243180. 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 SSPC NXT Delivery Catheter?

SSPC NXT Delivery Catheter is a medical device that received FDA 510(k) clearance on 2024-12-04. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K243180.

When was SSPC NXT Delivery Catheter approved by the FDA?

SSPC NXT Delivery Catheter received FDA 510(k) clearance on 2024-12-04, under approval number K243180.

What company makes SSPC NXT Delivery Catheter?

SSPC NXT Delivery Catheter is manufactured by CenterPoint Systems, LLC.

What is the FDA product code for SSPC NXT Delivery Catheter?

The FDA product code for SSPC NXT Delivery Catheter is 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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