Cleared Traditional

K102484 - SEQURE SNARE SYSTEM

K102484 is an FDA 510(k) clearance for SEQURE SNARE SYSTEM, manufactured by Lifetech Scientific (Shenzhen) Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K102484 · Lifetech Scientific (Shenzhen) Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
71d
Days
Class 2
Risk

K102484 is an FDA 510(k) clearance for the SEQURE SNARE SYSTEM. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Lifetech Scientific (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 9, 2010 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifetech Scientific (Shenzhen) Co., Ltd. devices

FDA 510(k) Submission Details - K102484

510(k) Number K102484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date November 09, 2010
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Dekra Certification B.V
ROBERT VAN BOXTEL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MMX Device, Percutaneous Retrieval

All 28
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K102484.
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RECRUIT MICROCATHETER
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MODIFICATION TO RADIUS SNARE
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