Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set

K-Number: K252707 · 2026-05-20

ApplicantSuzhou Zenith Vascular SciTech Limited
Decision Date2026-05-20
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K252707. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zenith Aspiration Catheter; Disposable Aspiration Tubing Set?

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K252707.

When did Zenith Aspiration Catheter; Disposable Aspiration Tubing Set receive FDA 510(k) clearance?

Zenith Aspiration Catheter; Disposable Aspiration Tubing Set received FDA 510(k) clearance on 2026-05-20, under 510(k) number K252707.

Who is the listed applicant for Zenith Aspiration Catheter; Disposable Aspiration Tubing Set?

The FDA 510(k) record lists Suzhou Zenith Vascular SciTech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenith Aspiration Catheter; Disposable Aspiration Tubing Set?

The FDA product code for Zenith Aspiration Catheter; Disposable Aspiration Tubing Set is NRY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06615713CLinical Evaluation of Aspiration for Removal ANd ClearancE of StonesCOMPLETED

Other records listing Suzhou Zenith Vascular SciTech Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253359Zenith Distal Access Long SheathK252317Zenith Micro GuidewireK243534Micro Catheter

Related Devices (Code: NRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑