DeviceClearance

Product code NRY— Cardiovascular

EMBOTRAP III Revascularization Device

Classification name
Catheter, Thrombus Retriever
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
114
First cleared
Most recent

FDA classification definition

“The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.”

— U.S. Food and Drug Administration, device classification record for product code NRY under 21 CFR 870.1250, via openFDA

Market context for product code NRY

FDA has cleared 114 devices under product code NRY between 2004 and 2026, filed by 24 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 NRY

Adverse events under product code NRY

product code NRY
Death
411
Injury
1,712
Malfunction
1,855
Total
3,978

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 NRY

1–100 of 114

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