Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device— 510(k) K230429

Name: FDA 510(k) clearance K230429
Creator: U.S. Food and Drug Administration
Published: 2023-04-17

Substantially Equivalent

Rapid Medical , Ltd.

FDA 510(k) clearance K230429 for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device, Substantially Equivalent on 2023-04-17. 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: 2023-02-17
Decision date: 2023-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)2026-07-16

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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.