Sequre Snare System

FDA 510(k) K102484 · Lifetech Scientific (Shenzhen) Co., Ltd.

Substantially Equivalent

510(k) numberK102484

Submission

Device name
Sequre Snare System
Applicant
Lifetech Scientific (Shenzhen) Co., Ltd.
Shenzhen, CN
Received
August 30, 2010
Decision date
November 9, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
MMX – Device, Percutaneous Retrieval
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

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Questions and answers

When was Sequre Snare System cleared by the FDA?

Sequre Snare System (K102484) received a 510(k) decision of Substantially Equivalent on November 9, 2010, 71 days after the submission was received.

What is the product code of K102484?

The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.