Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022
FDA 510(k) K991502 · Medtronic PS Medical
510(k) numberK991502
Submission
- Device name
- Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022
- Applicant
- Medtronic PS Medical
Goleta, CA, US - Received
- April 29, 1999
- Decision date
- September 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855JXG · Traditional | 02/11/2002SE |
| K010361 | Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900GXR · Traditional | 05/07/2001SE |
| K010487 | Bipolar Pencil, Model 3901-002, 3900-002GEI · Abbreviated | 05/03/2001SE |
| K010341 | Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157…GWG · Abbreviated | 04/20/2001SE |
| 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 |
| 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 |
| K983331 | Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional | 12/16/1998SE |
Questions and answers
When was Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022 cleared by the FDA?
Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022 (K991502) received a 510(k) decision of Substantially Equivalent on September 12, 2000, 502 days after the submission was received.
What is the product code of K991502?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.