510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K113214Substantially Equivalent

Tlink Data Management System (Dms)

Terumo Cardiovascular Systems Corporation, Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113214 is the FDA 510(k) clearance record for TLINK DATA MANAGEMENT SYSTEM (DMS), a class II device, cleared for Terumo Cardiovascular Systems Corp. on under FDA product code DXJ (Display, Cathode-Ray Tube, Medical). FDA records list 160 510(k) clearances for Terumo Cardiovascular Systems Corp., from to . As of , FDA records show no recalls naming K113214.

Clearance record

Decision date
Received
(99 days to decision)
Product code
DXJ Display, Cathode-Ray Tube, Medical
Regulation
21 CFR 870.2450
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Cardiovascular Systems Corp. 6200 Jackson Rd., Ann Arbor MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXJ

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