Home / 510(k) Clearances / K233445

510(k) K233445

Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter by Integra Lifesciences Production Corporation — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2024
Date Received
October 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Integra Lifesciences Production Corporation

  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K232890 — CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (February 4, 2024)
  • K233448 — Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (December 19, 2023)
  • K223330 — Certas Plus Programmable Valves (February 1, 2023)
  • K221840 — Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (October 14, 2022)
  • K210993 — CereLink ICP Monitor (April 30, 2021)

Other clearances for product code JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)