Zenith Aspiration Catheter; Disposable Aspiration Tubing Set— 510(k) K252707
Substantially EquivalentSuzhou Zenith Vascular SciTech Limited
FDA 510(k) clearance K252707 for Zenith Aspiration Catheter; Disposable Aspiration Tubing Set, Substantially Equivalent on 2026-05-20. Applicant: Suzhou Zenith Vascular SciTech Limited. Device class: 2.
Summary
Suzhou Zenith Vascular SciTech's record covers two items, the Zenith Aspiration Catheter and a Disposable Aspiration Tubing Set. The record lists one product code for both: NRY, thrombus retriever catheters.
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.
Zenith filed from Suzhou, China. Review took 266 calendar days (August 27, 2025 to May 20, 2026).
Clearance details
- Applicant
- Suzhou Zenith Vascular SciTech Limited
- 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
- Suzhou, CN
Recent devices under product code NRY
view all- K262021 — Toro 71 Aspiration Catheter; Toro Aspiration Tubing
- K263266 — Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- 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
More clearances from Suzhou Zenith Vascular SciTech Limited
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.