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510(k) K971617

ENDOSCOPIC VENTRICULAR CATHETER by Integra Neurocare, LLC — Product Code JXG

K971617 is an FDA 510(k) premarket notification submitted by Integra Neurocare, LLC for the device "ENDOSCOPIC VENTRICULAR CATHETER". The FDA issued a decision of Substantially Equivalent on July 31, 1997. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Neurocare, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1997
Date Received
May 2, 1997
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 Neurocare, LLC

  • K002392 — VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V (November 2, 2000)
  • K992006 — NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33 (August 17, 1999)
  • K981246 — BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850- (May 26, 1999)
  • K973525 — MAURICE WORLDWIDE SHUNT SYSTEM (December 16, 1997)
  • K972994 — EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS (November 3, 1997)
  • K972261 — RIVETTI-LEVINSON INSTRALUMINAL SHUNT (September 15, 1997)
  • K970983 — PERITONEAL/CARDIAC CATHETER (June 13, 1997)
  • K970658 — LUMBAR DRAINAGE ACCESSORY KIT (May 19, 1997)
  • K964371 — SHUNT TAP WITH ICP MONITORING ACCESS PORT (January 31, 1997)
  • K961859 — NOVUS STANDARD AND PEDIATRIC VALVES (December 16, 1996)

Other clearances for product code JXG

  • K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® P (June 23, 2026)
  • 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)

FDA data resources