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FDA 510(k)

NG Delivery Catheter

K-Number: K230609 · 2023-09-13

ApplicantBalt USA, LLC
Decision Date2023-09-13
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NG Delivery Catheter is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2023-09-13 under approval number K230609. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NG Delivery Catheter?

NG Delivery Catheter is a medical device that received FDA 510(k) clearance on 2023-09-13. It is manufactured by Balt USA, LLC. The 510(k) number is K230609.

When was NG Delivery Catheter approved by the FDA?

NG Delivery Catheter received FDA 510(k) clearance on 2023-09-13, under approval number K230609.

What company makes NG Delivery Catheter?

NG Delivery Catheter is manufactured by Balt USA, LLC.

What is the FDA product code for NG Delivery Catheter?

The FDA product code for NG Delivery Catheter is QJP.

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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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