Ant Inflation Device/Ant Inflation Device Compact Pack

FDA 510(k) K102648 · Shenzhen Ant Hi-Tech Industrial Co., Ltd.

Substantially Equivalent

510(k) numberK102648

Submission

Device name
Ant Inflation Device/Ant Inflation Device Compact Pack
Applicant
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Shenzhen, CN
Received
September 14, 2010
Decision date
July 1, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MAV – Syringe, Balloon Inflation
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1650
Specialty
Cardiovascular

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K140745Encore 26 Advantage KitMAV · Special Boston Scientific Corp04/17/2014SESK

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Questions and answers

When was Ant Inflation Device/Ant Inflation Device Compact Pack cleared by the FDA?

Ant Inflation Device/Ant Inflation Device Compact Pack (K102648) received a 510(k) decision of Substantially Equivalent on July 1, 2011, 290 days after the submission was received.

What is the product code of K102648?

The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.