FDA 510(k)

Integra DP 阀门系统（包括钻孔蓄水池和不锈钢连接器），重力补偿附件

K号: K152897 · 2016-03-04

决定日期2016-03-04

产品代码JXG

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决定实质等同

器械摘要

Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152897. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory?

Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K152897.

When did Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory receive FDA 510(k) clearance?

Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152897.

Who is the listed applicant for Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory?

The FDA product code for Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory is JXG.