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FDA 510(k)

AUTO-FILL SYRINGE KIT, MODEL 7600

K-Number: K063851 · 2007-01-26

ApplicantVascular Solutions, Inc.
Decision Date2007-01-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTO-FILL SYRINGE KIT, MODEL 7600 is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2007-01-26 under 510(k) number K063851. 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 AUTO-FILL SYRINGE KIT, MODEL 7600?

AUTO-FILL SYRINGE KIT, MODEL 7600 is a medical device that received FDA 510(k) clearance on 2007-01-26. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K063851.

When did AUTO-FILL SYRINGE KIT, MODEL 7600 receive FDA 510(k) clearance?

AUTO-FILL SYRINGE KIT, MODEL 7600 received FDA 510(k) clearance on 2007-01-26, under 510(k) number K063851.

Who is the listed applicant for AUTO-FILL SYRINGE KIT, MODEL 7600?

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

What is the FDA product code for AUTO-FILL SYRINGE KIT, MODEL 7600?

The FDA product code for AUTO-FILL SYRINGE KIT, MODEL 7600 is FMF.

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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

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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