Tigertriever 13 Ultra Revascularization Device— 510(k) K260617
Substantially EquivalentRapid 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.
Summary
Rapid Medical's Tigertriever 13 Ultra Revascularization Device is filed under product code NRY, thrombus retriever catheters. The record doesn't say what 13 or Ultra refers to in the name.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Rapid Medical filed from Yokneam, Israel. The decision came 184 calendar days after FDA received it (February 25 to August 28, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Rapid Medical Ltd.
- 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
- Traditional
- Location
- Yokneam, IL
Recent devices under product code NRY
view all- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
- K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing
- K262399 — Millipede System
- K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)
More clearances from Rapid Medical Ltd.
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.