PS Medical Button Valve
FDA 510(k) K911410 · Pudenz-Schulte Medical Research Corp.
510(k) numberK911410
Submission
- Device name
- PS Medical Button Valve
- Applicant
- Pudenz-Schulte Medical Research Corp.
Goleta, CA, US - Received
- April 1, 1991
- Decision date
- June 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional | Integra Lifesciences Production Corporation | 06/23/2026SE |
| K251598 | IntellidropJXG · Traditional | Brainspace, Inc. | 12/10/2025SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
| K252514 | Evac-MriJXG · Traditional | Phasor Health, LLC | 11/05/2025SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional | Integra Lifesciences Production Corporation | 08/08/2025SE |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | Sophysa | 06/20/2025SE |
| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960055 | Medtronic PS Medical Bioglide Vascular Catheter, SNGL Lumen Model Nos 8960 & 8932LJS · Traditional | 09/30/1996SE |
| K954409 | PS Medical Ipi Vascular Access CatheterLJS · Traditional | 12/18/1995SE |
| K951258 | PS Medical Bioglide Csf-Flow Control Shunt KitJXG · Traditional | 09/18/1995SE |
| K934796 | Ipi Low Profile ImportLJT · Traditional | 07/14/1994SE |
| K934167 | Ipi Dual Lumen PortLJT · Traditional | 07/14/1994SE |
| K940096 | PS Medical Catheter Placement KitGWG · Traditional | 05/03/1994SE |
| K934545 | PS Medical Delta Burr Hole ValveJXG · Traditional | 04/28/1994SE |
| K930206 | PS Medical Ipi Access KitLJT · Traditional | 02/25/1994SESK |
| K930606 | PS Medical Disposable Subcutaneous Cath PasserGYK · Traditional | 09/10/1993SE |
| K913412 | PS Medical Csf-Access DeviceJXG · Traditional | 03/30/1993SE |
Questions and answers
When was PS Medical Button Valve cleared by the FDA?
PS Medical Button Valve (K911410) received a 510(k) decision of Substantially Equivalent on June 28, 1991, 88 days after the submission was received.
What is the product code of K911410?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.