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510(k) K970983

PERITONEAL/CARDIAC CATHETER by Integra Neurocare, LLC — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1997
Date Received
March 18, 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)
  • K971617 — ENDOSCOPIC VENTRICULAR CATHETER (July 31, 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)

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