Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855
FDA 510(k) K012052 · Medtronic PS Medical
510(k) numberK012052
Submission
- Device name
- Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855
- Applicant
- Medtronic PS Medical
Goleta, CA, US - Received
- July 2, 2001
- Decision date
- February 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 cleared by the FDA?
Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 (K012052) received a 510(k) decision of Substantially Equivalent on February 11, 2002, 224 days after the submission was received.
What is the product code of K012052?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.