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FDA 510(k)

Primero Safe Access System

K-Number: K252441 · 2025-09-29

ApplicantSouth53, LLC
Decision Date2025-09-29
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Primero Safe Access System is a medical device manufactured by South53, LLC. It received FDA 510(k) clearance on 2025-09-29 under approval number K252441. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Primero Safe Access System?

Primero Safe Access System is a medical device that received FDA 510(k) clearance on 2025-09-29. It is manufactured by South53, LLC. The 510(k) number is K252441.

When was Primero Safe Access System approved by the FDA?

Primero Safe Access System received FDA 510(k) clearance on 2025-09-29, under approval number K252441.

What company makes Primero Safe Access System?

Primero Safe Access System is manufactured by South53, LLC.

What is the FDA product code for Primero Safe Access System?

The FDA product code for Primero Safe Access System is DYB.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (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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