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FDA 510(k)

ARTSANA PISTON AND INSULIN SYRINGES

K-Number: K052667 · 2005-11-25

ApplicantArtsana S.P.A
Decision Date2005-11-25
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARTSANA PISTON AND INSULIN SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Artsana S.P.A. It received FDA 510(k) clearance on 2005-11-25 under 510(k) number K052667. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTSANA PISTON AND INSULIN SYRINGES?

ARTSANA PISTON AND INSULIN SYRINGES is a medical device that received FDA 510(k) clearance on 2005-11-25. The listed applicant is Artsana S.P.A. The 510(k) number is K052667.

When did ARTSANA PISTON AND INSULIN SYRINGES receive FDA 510(k) clearance?

ARTSANA PISTON AND INSULIN SYRINGES received FDA 510(k) clearance on 2005-11-25, under 510(k) number K052667.

Who is the listed applicant for ARTSANA PISTON AND INSULIN SYRINGES?

The FDA 510(k) record lists Artsana S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTSANA PISTON AND INSULIN SYRINGES?

The FDA product code for ARTSANA PISTON AND INSULIN SYRINGES is FMF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Artsana S.P.A as applicant

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.

K151311Safe Block Pen NeedleK051783ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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