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FDA PRODUCT CODE · CLASS II

QJP — Catheter, Percutaneous, Neurovasculature

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1250
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
39
510(K)/PMA CLEARANCES
510k: 39
0
RECALL ENTRIES

Recent clearances

K260199Balt USA, LLC · 510k2026-07-13
K253901Perfuze, Ltd. · 510k2026-07-09
K261889Stryker Neurovascular · 510k2026-07-01
K261808Microvention Inc. d/b/a Terumo Neuro · 510k2026-06-30
K261549MicroVention, Inc., d/b/a Terumo Neuro · 510k2026-06-09
K253359Suzhou Zenith Vascular SciTech Limited · 510k2026-05-22
K254178Asahi Intecc Co., Ltd. · 510k2026-05-11
K254046Sonorous NV, Inc. · 510k2026-04-21

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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