510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K140768Substantially Equivalent

Type I Brilliant Introducer Kit, Type II Brilliant Introducer Kit, Type III Brilliant Introducer Kit, Type IV Brilliant

Lepu Medical Technology (Bejing) Co., Ltd., South Euclid OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140768 is the FDA 510(k) clearance record for TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT, a class II device, cleared for Lepu Medical Technology (Bejing) Co., Ltd. on under FDA product code DYB (Introducer, Catheter). FDA records list one 510(k) clearance for Lepu Medical Technology (Bejing) Co., Ltd. As of , FDA records show no recalls naming K140768.

Clearance record

Decision date
Received
(243 days to decision)
Product code
DYB Introducer, Catheter
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Lepu Medical Technology (Bejing) Co., Ltd. 1531 Felton Rd., South Euclid OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DYB

Trailing 12 months
18 clearances under product code DYB in the twelve months to October 2026, April 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code DYB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20261
February 20262
March 20261
April 20267
May 20260
June 20263
July 20262
August 20260
September 20260
October 20260