PS Medical Ventriculostomy Kit
FDA 510(k) K915546 · Pudenz-Schulte Medical Research Corp.
510(k) numberK915546
Submission
- Device name
- PS Medical Ventriculostomy Kit
- Applicant
- Pudenz-Schulte Medical Research Corp.
Goleta, CA, US - Received
- December 11, 1991
- Decision date
- December 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Neurodynamics, 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 Ventriculostomy Kit cleared by the FDA?
PS Medical Ventriculostomy Kit (K915546) received a 510(k) decision of Substantially Equivalent on December 30, 1991, 19 days after the submission was received.
What is the product code of K915546?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.