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FDA PRODUCT CODE · CLASS II

NRY — Catheter, Thrombus Retriever

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1250
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
26
510(K)/PMA CLEARANCES
510k: 26
0
RECALL ENTRIES

Recent clearances

K260002Scientia Vascular, Inc. · 510k2026-07-16
K250690Penumbra, Inc. · 510k2026-06-10
K252707Suzhou Zenith Vascular SciTech Limited · 510k2026-05-20
K254276Q’Apel Medical, Inc. · 510k2026-05-07
K253590Perfuze, Ltd. · 510k2026-03-16
K253062Rapid Medical Ltd. · 510k2026-03-12
K251357Phenox, Ltd. · 510k2026-01-15
K251006Vesalio, Inc. · 510k2025-11-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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