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

Catheter, Intracardiac Mapping, High-Density Array

21 CFR 870.1220 / Cardiovascular
FDA source (opens on fda.gov)

MTD is the FDA product code for Catheter, Intracardiac Mapping, High-Density Array, a class II device type, regulated under 21 CFR 870.1220. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
MTD
Device name
Catheter, Intracardiac Mapping, High-Density Array
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
34
Ingested recalls
9

Clearances, product code MTD

By decision year
34 clearances under product code MTD with a decision year between 1999 and 2026, 1999 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MTD by decision year
YearClearances
19995
20001
20012
20021
20051
20122
20132
20142
20161
20172
20181
20204
20211
20222
20233
20242
20262

Applicants with the most clearances

Product code MTD
Applicants holding the most 510(k) clearances under product code MTD
ApplicantClearances
Biosense Webster Inc8
Boston Scientific Corporation6
Abbott Medical3
Acutus Medical, Inc.3
Abbott Electrophysiology2
Cardiac Pathways Corp.2
Cortex, Inc.2
Endocardial Solutions, Inc.2
Topera, Inc.2
Ablacon, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order