Tigertriever 13 Ultra Revascularization Device— 510(k) K260617

Name: FDA 510(k) clearance K260617
Creator: U.S. Food and Drug Administration
Published: 2026-08-28

Substantially Equivalent

Rapid Medical Ltd.

FDA 510(k) clearance K260617 for Tigertriever 13 Ultra Revascularization Device, Substantially Equivalent on 2026-08-28. Applicant: Rapid Medical Ltd.. Device class: 2.

Clearance details

Applicant: Rapid Medical Ltd.
Product code: Code NRY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2026-02-25
Decision date: 2026-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code NRY

view all

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
K250690 — Penumbra System (Thunderbolt Aspiration Tubing)2026-06-10

More clearances from Rapid Medical Ltd.

view all

K254006 — Drivewire 35 Guidewire2026-07-17
K253062 — Tigertriever 25 Revascularization Device2026-03-12
K251603 — Tigertriever 17 Ultra Revascularization Device2025-10-06
K233791 — Drivewire 24 Guidewire2024-07-11
DEN230064 — BraidE Embolization Assist Device2024-02-21

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.