510(k) Report

510(k) · Cleared

Cleared

Sequre Snare System

K102484510(k) TraditionalCleared Nov 9, 201071-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lifetech Scientific (Shenzhen) Co., Ltd. · MMX Device, Percutaneous Retrieval

Cleared on Nov 9, 2010 as substantially equivalent to K972511 (Microvena Corp., 1998) after a 71-day review. Its family tree reaches back 2 generations to 1990.

Decided
Nov 9, 2010
Review
71 days
Class
Class II
Product code
MMX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K901502 (1990). No later device cites it as a predicate yet.

  1. Root · 2 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
  2. 1 generation backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
  3. This deviceK102484 Sequre Snare SystemLifetech Scientific (Shenzhen) Co., Ltd. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K901502Amplatz Goose-Neck SnareMicrovena Corp.19901
−1K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp.19981
0 (this device)K102484Sequre Snare SystemLifetech Scientific (Shenzhen) Co., Ltd.2010—
FIG. 1 — Lineage of K102484, 1990–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MMX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MMX device

  1. #1 K242776 LimFlow V-Ceiverscore 10.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K972511Amplatz Goose Neck Snare Kit/ Catheter
Summary page 1
…nare System Classification: Class 11,IMMX, 21 CFIR 870.5150 Catheter, Percutaneous Predicate Device: ev3 Amplatz 'Goose Neck" Snare Device as cleared inK97251 1. Intended Use: The SeQurerm Snare System is intended for use inthe cardiovascular system as a tool to retrieve and manipulate fo…
Microvena Corp.19981

Also cleared against K972511: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 12.7 years on median.
  • 2 of the 2 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K972511.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MMX

1in 2025

2007: 12009: 22010: 12011: 12012: 12014: 22015: 22016: 22017: 22018: 12019: 12020: 22021: 12022: 32023: 22024: 12025: 1
2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2022: 151 days median
2007high 151 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MMX

No recall names MMX since 2007.

Adverse event reports per year · MMX

49in 2025

2007: 22008: 62009: 62010: 112011: 152012: 132013: 102014: 112015: 52016: 162017: 292018: 152019: 172020: 142021: 222022: 372023: 402024: 322025: 49
2007high 49 (2025) · low 2 (2007)2025

MAUDE reports naming product code MMX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20080—06
20092—06
20101—011
20111—015
20121—013
20130—010
20142—011
20152—05
20162—016
20172—029
20181—015
20191—017
20202—014
20211—022
20223151037
20232—040
20241—032
20251—049
20260—0—

What is it indicated for?

The SeQure™ Snare System is intended for use in the cardiovascular system as a tool to retrieve and manipulate foreign objects.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K102484: Sequre Snare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102484

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026