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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

21 CFR 870.5100 / Cardiovascular
FDA source (opens on fda.gov)

LOX is the FDA product code for Catheters, Transluminal Coronary Angioplasty, Percutaneous, a class II device type, regulated under 21 CFR 870.5100. FDA's definition for this code reads: "A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end". As of , FDA records hold 88 510(k) clearances under this code, the most recent dated , and 121 recalls.

Classification record

Product code
LOX
Device name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA definition
A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Regulation
21 CFR 870.5100
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
88
Ingested recalls
121

Clearances, product code LOX

By decision year
88 clearances under product code LOX with a decision year between 1982 and 2026, 2012 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code LOX by decision year
YearClearances
19821
19851
19861
19901
20102
20117
201210
20136
20146
20154
20169
20176
20187
20191
20201
20216
20225
20234
20244
20266

Applicants with the most clearances

Product code LOX
Applicants holding the most 510(k) clearances under product code LOX
ApplicantClearances
Boston Scientific Corporation10
Abbott Vascular6
Verge Medical Inc.6
BrosMed Medical Co.,Ltd.5
Trireme Medical, Inc.5
Medtronic Ireland4
Orbusneich Medical Trading, Inc.4
Orbusneich Medical, Inc.4
Abbott Vascular-Cardiac Therapies3
BIOTRONIK AG3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order