APRO 35 Swift Catheter— 510(k) K262392

Name: FDA 510(k) clearance K262392
Creator: U.S. Food and Drug Administration
Published: 2026-08-12

Substantially Equivalent

Alembic, LLC

FDA 510(k) clearance K262392 for APRO 35 Swift Catheter, Substantially Equivalent on 2026-08-12. Applicant: Alembic, LLC. Device class: 2.

Clearance details

Applicant: Alembic, LLC
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2026-07-14
Decision date: 2026-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K260559 — NHanceIT2026-08-14
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02
K261631 — Amplatzer TorqVue Exchange System2026-06-17

More clearances from Alembic, LLC

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K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing2026-08-12
K251014 — APRO 45 Catheter2025-05-01
K251015 — APRO 45 Catheter and Alembic Aspiration Tubing2025-04-30
K250962 — APRO 55 Intermediate Catheter2025-04-29
K250958 — APRO 55 Swift Catheter and Alembic Aspiration Tubing2025-04-28

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.