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FDA 510(k)

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

K-Number: K233448 · 2023-12-19

ApplicantIntegra Lifesciences Production Corporation
Decision Date2023-12-19
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is a medical device manufactured by Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2023-12-19 under approval number K233448. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is a medical device that received FDA 510(k) clearance on 2023-12-19. It is manufactured by Integra Lifesciences Production Corporation. The 510(k) number is K233448.

When was Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set approved by the FDA?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set received FDA 510(k) clearance on 2023-12-19, under approval number K233448.

What company makes Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is manufactured by Integra Lifesciences Production Corporation.

What is the FDA product code for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

The FDA product code for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set is JXG.

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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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