Visualized Access and Delivery Catheter; PB Digital Controller— 510(k) K252492

Substantially Equivalent

Micro-Tech (Nanjing) Co., Ltd.

FDA 510(k) clearance K252492 for Visualized Access and Delivery Catheter; PB Digital Controller, Substantially Equivalent on 2026-04-24. Applicant: Micro-Tech (Nanjing) Co., Ltd..

Clearance details

Applicant: Micro-Tech (Nanjing) Co., Ltd.
Product code: Code SHU
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-08
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, CN

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