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FDA 510(k)

Visualized Access and Delivery Catheter; PB Digital Controller

K-Number: K252492 · 2026-04-24

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2026-04-24
Product CodeSHU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Visualized Access and Delivery Catheter; PB Digital Controller is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-24 under approval number K252492. The device is classified under product code SHU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visualized Access and Delivery Catheter; PB Digital Controller?

Visualized Access and Delivery Catheter; PB Digital Controller is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K252492.

When was Visualized Access and Delivery Catheter; PB Digital Controller approved by the FDA?

Visualized Access and Delivery Catheter; PB Digital Controller received FDA 510(k) clearance on 2026-04-24, under approval number K252492.

What company makes Visualized Access and Delivery Catheter; PB Digital Controller?

Visualized Access and Delivery Catheter; PB Digital Controller is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Visualized Access and Delivery Catheter; PB Digital Controller?

The FDA product code for Visualized Access and Delivery Catheter; PB Digital Controller is SHU.

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Related PubMed Literature

PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

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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.

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