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

Guide, Wire, Catheter, Neurovasculature

21 CFR 870.1330 / Cardiovascular
FDA source (opens on fda.gov)

MOF is the FDA product code for Guide, Wire, Catheter, Neurovasculature, a class II device type, regulated under 21 CFR 870.1330. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
MOF
Device name
Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
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
Yes
Ingested clearances
45
Ingested recalls
2

Clearances, product code MOF

By decision year
45 clearances under product code MOF with a decision year between 2011 and 2026, 2026 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code MOF by decision year
YearClearances
20112
20142
20153
20164
20171
20182
20194
20204
20221
20234
20242
20255
202611

Applicants with the most clearances

Product code MOF
Applicants holding the most 510(k) clearances under product code MOF
ApplicantClearances
Asahi Intecc Co., Ltd.10
Scientia Vascular8
Terumo Cardiovascular Systems Corporation6
Arbor Endovascular5
Rapid Medical Inc.3
Stryker Corp.2
Artiria Medical SA1
Balt USA, LLC1
Cerenovus, Inc.1
Enlight Medical Technologies (Shenzhen) Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order