Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

K-Number: K233445 · 2024-01-17

ApplicantIntegra Lifesciences Production Corporation
Decision Date2024-01-17
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter is a medical device manufactured by Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2024-01-17 under approval number K233445. 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 Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter?

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter is a medical device that received FDA 510(k) clearance on 2024-01-17. It is manufactured by Integra Lifesciences Production Corporation. The 510(k) number is K233445.

When was Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter approved by the FDA?

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter received FDA 510(k) clearance on 2024-01-17, under approval number K233445.

What company makes Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter?

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter is manufactured by Integra Lifesciences Production Corporation.

What is the FDA product code for Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter?

The FDA product code for Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter is JXG.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07537153 Genicular Artery Embolization for Knee Osteoarthritis RECRUITING

Other Devices by Integra Lifesciences Production Corporation

K210993CereLink ICP Monitor K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus Programmable Valves K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

View all 8 devices →

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences 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.

↑