Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102
FDA 510(k) K983331 · Medtronic PS Medical
510(k) numberK983331
Submission
- Device name
- Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102
- Applicant
- Medtronic PS Medical
Goleta, CA, US - Received
- September 22, 1998
- Decision date
- December 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K003914 | Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesGWG · Abbreviated | 02/22/2001SE |
| K002572 | Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003…GWG · Abbreviated | 11/16/2000SE |
| K991502 | Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022JXG · Traditional | 09/12/2000SE |
| K990333 | Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015GWG · Traditional | 04/28/1999SE |
| K984053 | Becker External Drainage and Monitoring SystemJXG · Traditional | 02/04/1999SE |
| K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System…GWM · Traditional | 01/26/1999SE |
Questions and answers
When was Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102 cleared by the FDA?
Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102 (K983331) received a 510(k) decision of Substantially Equivalent on December 16, 1998, 85 days after the submission was received.
What is the product code of K983331?
The FDA product code is HCA – Catheter, Ventricular, a Class II (moderate risk) device regulated under 21 CFR 882.4100.