FDA 510(k)

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set

Número K: K250907 · 2025-04-30

Data da decisão2025-04-30

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Sol-Millennium Medical, Inc.. It received FDA 510(k) clearance on 2025-04-30 under 510(k) number K250907. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is a medical device that received FDA 510(k) clearance on 2025-04-30. The listed applicant is Sol-Millennium Medical, Inc.. The 510(k) number is K250907.

When did Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set receive FDA 510(k) clearance?

Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set received FDA 510(k) clearance on 2025-04-30, under 510(k) number K250907.

Who is the listed applicant for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

The FDA 510(k) record lists Sol-Millennium Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set?

The FDA product code for Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set is JKA.

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Outros registros que listam Sol-Millennium Medical, Inc. como candidato(a)

K252184SOL-M Luer Lock Syringe with Exchangeable Needle Tray K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle K220713Sol-Guard Auto-disable Syringe

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Fonte oficial

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