510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080901Unknown

Lbi Embolectomy System

Lumen Biomedical, Inc., Plymouth MN / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080901 is the FDA 510(k) clearance record for LBI EMBOLECTOMY SYSTEM, a class II device, cleared for Lumen Biomedical, Inc. on under FDA product code QEW (Peripheral Mechanical Thrombectomy With Aspiration). FDA's definition for product code QEW reads: "To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration". FDA records list 5 510(k) clearances for Lumen Biomedical, Inc., from to . As of , FDA records show no recalls naming K080901.

Clearance record

Decision date
Received
(185 days to decision)
Product code
QEW Peripheral Mechanical Thrombectomy With Aspiration
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Lumen Biomedical, Inc. 14505 21st Ave. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEW

Trailing 12 months
11 clearances under product code QEW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEW, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20262
March 20260
April 20261
May 20260
June 20260
July 20260
August 20262
September 20262
October 20260