Medical Device Manufacturer · US , Valley Forge , PA

Phoenix Biomedical Corp. - FDA 510(k) Cleared Devices

12 submissions · 11 cleared · Since 1996

Recent clearances: ACURA ELITE GRAVITY COMPENSATING RESERVOIR, ACCURA ELITE SHUNT SYSTEM, PHOENIX UNIVERSAL SHUNT SYSTEM

View 12 510(k) Devices ↓

12

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Phoenix Biomedical Corp. Neurology ✕

10 devices

1-10 of 10

Cleared Oct 15, 2003

ACURA ELITE GRAVITY COMPENSATING RESERVOIR

Neurology · 245d

Cleared Jan 27, 2003

ACCURA ELITE SHUNT SYSTEM

Neurology · 52d

Cleared Jan 27, 2003

PHOENIX UNIVERSAL SHUNT SYSTEM

Neurology · 46d

Cleared Aug 06, 2002

PERF (OMMAYA STYLE) RESERVOIRS

Neurology · 78d

Cleared Nov 09, 2000

LUMBOPERITONEAL SHUNT SYSTEM

Neurology · 90d

Cleared May 10, 2000

RUMBAR DRAINAGE SYSTEM

Neurology · 84d

Cleared May 19, 1999

DIAMOND II VALVE

Neurology · 23d

Cleared Apr 01, 1999

CRX WORLD SHUNT

Neurology · 64d

Cleared Dec 08, 1998

CRX DIAMOND VALVE

Neurology · 404d

Cleared Aug 27, 1996

PHOENIX CRX VALVE

Neurology · 209d