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

Endovascular Suturing System

21 CFR 870.3460 / Cardiovascular
FDA source (opens on fda.gov)

OTD is the FDA product code for Endovascular Suturing System, a class II device type, regulated under 21 CFR 870.3460. FDA's definition for this code reads: "Provides fixation and sealing between and endovascular graft and the native artery". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OTD
Device name
Endovascular Suturing System
FDA definition
Provides fixation and sealing between and endovascular graft and the native artery.
Regulation
21 CFR 870.3460
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code OTD

By decision year
7 clearances under product code OTD with a decision year between 2011 and 2018, 2014 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OTD by decision year
YearClearances
20111
20121
20131
20142
20171
20181

Applicants with the most clearances

Product code OTD
Applicants holding the most 510(k) clearances under product code OTD
ApplicantClearances
Aptus Endosystems, Inc.5
Medtronic, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code