APRO 35 Swift Catheter and Alembic Aspiration Tubing— 510(k) K262391
Substantially EquivalentAlembic, LLC
FDA 510(k) clearance K262391 for APRO 35 Swift Catheter and Alembic Aspiration Tubing, Substantially Equivalent on 2026-08-12. Applicant: Alembic, LLC. Device class: 2.
Summary
Alembic filed the APRO 35 Swift Catheter and Alembic Aspiration Tubing under product code NRY, thrombus retriever catheters. The record doesn't say what APRO or 35 refers to.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Special 510(k), though the record lists Cardiovascular as the classification panel.
Alembic filed from Mountain View, California. The substantially equivalent decision came 29 calendar days after receipt (July 14 to August 12, 2026).
Clearance details
- Applicant
- Alembic, LLC
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Recent devices under product code NRY
view all- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- K262399 — Millipede System
- K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)
More clearances from Alembic, LLC
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.