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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 the device name listed in this FDA 510(k) record. The listed applicant is Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2023-12-19 under 510(k) 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. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K233448.

When did Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set?

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

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.

Other records listing Integra Lifesciences Production Corporation as applicant

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterK223330Certas Plus Programmable Valves

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Related Devices (Code: JXG)

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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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