510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213868Substantially Equivalent

ASAHI Gladius Mongo18 PV ES

Asahi Intecc Co., Ltd., Seto, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213868 is the FDA 510(k) clearance record for ASAHI Gladius Mongo18 PV ES, a class II device, cleared for Asahi Intecc Co., Ltd. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 84 510(k) clearances for Asahi Intecc Co., Ltd., from to . As of , FDA records show no recalls naming K213868.

Clearance record

Decision date
Received
(270 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Asahi Intecc Co., Ltd. 3-100 Akatsuki-Cho, Seto, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260