Zenith Distal Access Long Sheath

FDA 510(k) K253359 · Suzhou Zenith Vascular SciTech Limited

Substantially Equivalent

510(k) numberK253359

Submission

Device name
Zenith Distal Access Long Sheath
Applicant
Suzhou Zenith Vascular SciTech Limited
Suzhou, CN
Received
September 30, 2025
Decision date
May 22, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QJP – Catheter, Percutaneous, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Other 510(k)s with product code QJP

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K26227770 NeuGlide CatheterQJP · Special Piraeus Medical, Inc.09/04/2026SE
K261176Zoom 4S CatheterQJP · Traditional Imperative Care, Inc.08/28/2026SE
K254071p17 XR MicrocatheterQJP · Traditional Wallaby Medical08/18/2026SE
K260199SLIM MicrocatheterQJP · Traditional Balt USA, LLC07/13/2026SE
K253901Millipede88 Access CatheterQJP · Traditional Perfuze, Ltd.07/09/2026SE
K261889Trevo Trak 21 MicrocatheterQJP · Special Stryker Neurovascular07/01/2026SE
K261808ISAAC Neurovascular Navigation CatheterQJP · Special Microvention Inc. d/b/a Terumo Neuro06/30/2026SE
K261549BOBBY Balloon Guide CatheterQJP · Special MicroVention, Inc., d/b/a Terumo Neuro06/09/2026SE
K254178SAYA 86 Radial Access Guide CatheterQJP · Traditional Asahi Intecc Co., Ltd.05/11/2026SE
K254046BosCATH Support CatheterQJP · Traditional Sonorous NV, Inc.04/21/2026SE

More from Sonorous NV, Inc.

510(k)DeviceDecision
K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional 05/20/2026SE
K252317Zenith Micro GuidewireMOF · Traditional 04/16/2026SE
K243534Micro CatheterKRA · Traditional 07/30/2025SE

Questions and answers

When was Zenith Distal Access Long Sheath cleared by the FDA?

Zenith Distal Access Long Sheath (K253359) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 234 days after the submission was received.

What is the product code of K253359?

The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.