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510(k) K033017

PHOENIX INFUSION CATHETER by Phoenix Biomedical — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2004
Date Received
September 26, 2003
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 Phoenix Biomedical

  • K030468 — ACURA ELITE GRAVITY COMPENSATING RESERVOIR (October 15, 2003)
  • K024040 — ACCURA ELITE SHUNT SYSTEM (January 27, 2003)
  • K024101 — PHOENIX UNIVERSAL 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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  • 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)