510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082519Substantially Equivalent

Finecross Mg Coronary Micro-Guide Catheter

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082519 is the FDA 510(k) clearance record for FINECROSS MG CORONARY MICRO-GUIDE CATHETER, a class II device, cleared for Terumo Medical Corp. on under FDA product code KRA (Catheter, Continuous Flush). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K082519.

Clearance record

Decision date
Received
(24 days to decision)
Product code
KRA Catheter, Continuous Flush
Regulation
21 CFR 870.1210
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Medical Corp. 950 Elkton Blvd., Elkton MD
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KRA

Trailing 12 months
5 clearances under product code KRA in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20262
October 20260