DeviceClearance

Product code LOX— Cardiovascular

Sapphire II PRO

Classification name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device class
Class 2
Regulation
21 CFR 870.5100
Advisory panel
Cardiovascular
Total cleared
88
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code LOX under 21 CFR 870.5100, via openFDA

Market context for product code LOX

FDA has cleared 88 devices under product code LOX between 1982 and 2026, filed by 36 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LOX

Adverse events under product code LOX

product code LOX
Death
190
Injury
1,498
Malfunction
9,670
Total
11,358

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LOX

Data sourced from openFDA. This site is unofficial and independent of the FDA.