510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183361Substantially Equivalent

EkoSonic Endovascular Device with Control Unit 4.0

Btg International, Inc., Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183361 is the FDA 510(k) clearance record for EkoSonic Endovascular Device with Control Unit 4.0, a class II device, cleared for Btg International, Inc. on under FDA product code QEY (Mechanical Thrombolysis Catheter). FDA's definition for product code QEY reads: "To mechanically disrupt thrombus and/or debris in the peripheral vasculature". FDA records list 6 510(k) clearances for Btg International, Inc., from to . As of , FDA records show 2 recalls naming K183361.

Clearance record

Decision date
Received
(122 days to decision)
Product code
QEY Mechanical Thrombolysis Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Btg International, Inc. 11911 N. Creek Pkwy. S., Bothell WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEY

Trailing 12 months
2 clearances under product code QEY in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QEY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260