Lynx Aspiration Catheter System— 510(k) K254276

Name: FDA 510(k) clearance K254276
Creator: U.S. Food and Drug Administration
Published: 2026-05-07

Substantially Equivalent

QApel Medical, Inc.

FDA 510(k) clearance K254276 for Lynx Aspiration Catheter System, Substantially Equivalent on 2026-05-07. Applicant: QApel Medical, Inc.. Device class: 2.

Clearance details

Applicant: QApel Medical, Inc.
Product code: Code NRY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2025-12-30
Decision date: 2026-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NRY

view all

K260617 — Tigertriever 13 Ultra Revascularization Device2026-08-28
K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set2026-08-13
K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing2026-08-12
K262399 — Millipede System2026-08-12
K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)2026-07-16

More clearances from QApel Medical, Inc.

view all

K240746 — Neurovascular Access System Family2024-11-20
K222786 — 072 Aspiration System2023-08-25
K230322 — SelectFlex Neurovascular Access System Family2023-06-22
K211893 — SelectFlex Neurovascular Access System Family2021-08-05

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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