Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
FDA 510(k) K152897 · Integra LifeSciences Corporation
510(k) numberK152897
Submission
- Device name
- Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
- Applicant
- Integra LifeSciences Corporation
Planisboro, NJ, US - Received
- October 1, 2015
- Decision date
- March 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory cleared by the FDA?
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory (K152897) received a 510(k) decision of Substantially Equivalent on March 4, 2016, 155 days after the submission was received.
What is the product code of K152897?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.