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510(k) K024101

PHOENIX UNIVERSAL SHUNT SYSTEM by Phoenix Biomedical Corp. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2003
Date Received
December 12, 2002
Clearance Type
Special
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 Phoenix Biomedical Corp.

  • K033017 — PHOENIX INFUSION CATHETER (April 7, 2004)
  • K030468 — ACURA ELITE GRAVITY COMPENSATING RESERVOIR (October 15, 2003)
  • K024040 — ACCURA ELITE SHUNT SYSTEM (January 27, 2003)
  • K021644 — PERF (OMMAYA STYLE) RESERVOIRS (August 6, 2002)
  • K002476 — LUMBOPERITONEAL SHUNT SYSTEM (November 9, 2000)
  • K000514 — RUMBAR DRAINAGE SYSTEM (May 10, 2000)
  • K991429 — DIAMOND II VALVE (May 19, 1999)
  • K990256 — CRX WORLD SHUNT (April 1, 1999)
  • K974096 — CRX DIAMOND VALVE (December 8, 1998)
  • K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEM (January 14, 1997)

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  • 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)