Perf (Ommaya Style) Reservoirs

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K021644 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Rumbar Drainage System

  Class II

  FDA 510(k) K000514 Active Cleared 10 May 2000

• Suture Cord

  Class II

  FDA 510(k) K953128 Active Cleared 9 Feb 1996

• Diamond II Valve

  Class II

  FDA 510(k) K991429 Active Cleared 19 May 1999

• Accura Elite Shunt System

  Class II

  FDA 510(k) K024040 Active Cleared 27 Jan 2003

• Crx Diamond Valve

  Class II

  FDA 510(k) K974096 Active Cleared 8 Dec 1998

• Lumboperitoneal Shunt System

  Class II

  FDA 510(k) K002476 Active Cleared 9 Nov 2000

See all devices from Phoenix Biomedical Corp. →

• What is the Perf (Ommaya Style) Reservoir used for?

  The Perf (Ommaya Style) Reservoirs are designed as part of a central nervous system shunt system to provide subcutaneous access to cerebrospinal fluid (CSF). They enable repeated hypodermic punctures for therapeutic interventions such as CSF sampling or medication administration, particularly in neurosurgical settings where direct ventricular access is required.

• Are these reservoirs intended for single-use or reuse?

  The Perf (Ommaya Style) Reservoirs are supplied sterile and labeled for single-use. However, they may be reused under strict sterile conditions as determined by clinical protocol, provided proper aseptic techniques are followed during handling and reprocessing.

• How are these reservoirs stored and handled?

  Storage and handling must comply with sterile medical device protocols to maintain integrity and sterility. Since they are implanted subcutaneously, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use, following manufacturer guidelines for sterile packaging.

• What regulatory approvals apply to these reservoirs?

  These reservoirs are regulated under the FDA 510(k) clearance process, specifically under clearance number K021644. They fall under the Central Nervous System Fluid Shunt and Components category (Regulation Number 882.5550) and are classified as substantially equivalent to predicate devices.

• Are there multiple model variants available for these reservoirs?

  Yes, multiple model variants of the Perf (Ommaya Style) Reservoirs are available, each identified by unique registration numbers. These variants are designed to accommodate different clinical needs within neurosurgical applications, ensuring compatibility with various shunt systems and patient anatomies.