Acura Elite Gravity Compensating Reservoir
FDA 510(k) K030468 · Phoenix Biomedical Corp.
510(k) numberK030468
Submission
- Device name
- Acura Elite Gravity Compensating Reservoir
- Applicant
- Phoenix Biomedical Corp.
Valley Forge, PA, US - Received
- February 12, 2003
- Decision date
- October 15, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033017 | Phoenix Infusion CatheterJXG · Traditional | 04/07/2004SE |
| K024101 | Phoenix Universal Shunt SystemJXG · Special | 01/27/2003SE |
| K024040 | Accura Elite Shunt SystemJXG · Special | 01/27/2003SE |
| K021644 | Perf (Ommaya Style) ReservoirsJXG · Traditional | 08/06/2002SE |
| K002476 | Lumboperitoneal Shunt SystemJXG · Traditional | 11/09/2000SE |
| K000514 | Rumbar Drainage SystemJXG · Traditional | 05/10/2000SE |
| K991429 | Diamond II ValveJXG · Special | 05/19/1999SE |
| K990256 | CRX World ShuntJXG · Special | 04/01/1999SE |
| K974096 | CRX Diamond ValveJXG · Traditional | 12/08/1998SE |
| K962144 | Phoenix Ete Tissue Extension SystemMKY · Traditional | 01/14/1997SE |
Questions and answers
When was Acura Elite Gravity Compensating Reservoir cleared by the FDA?
Acura Elite Gravity Compensating Reservoir (K030468) received a 510(k) decision of Substantially Equivalent on October 15, 2003, 245 days after the submission was received.
What is the product code of K030468?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.