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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 the device name listed in this FDA 510(k) record. The listed applicant is South53, LLC. It received FDA 510(k) clearance on 2025-09-29 under 510(k) 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. The listed applicant is South53, LLC. The 510(k) number is K252441.

When did Primero Safe Access System receive FDA 510(k) clearance?

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

Who is the listed applicant for Primero Safe Access System?

The FDA 510(k) record lists South53, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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