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FDA 510(k)

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT

K-Number: K050770 · 2005-04-14

ApplicantMckinley Medical, LLC
Decision Date2005-04-14
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mckinley Medical, LLC. It received FDA 510(k) clearance on 2005-04-14 under 510(k) number K050770. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT?

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2005-04-14. The listed applicant is Mckinley Medical, LLC. The 510(k) number is K050770.

When did MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT receive FDA 510(k) clearance?

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT received FDA 510(k) clearance on 2005-04-14, under 510(k) number K050770.

Who is the listed applicant for MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT?

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

What is the FDA product code for MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT?

The FDA product code for MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT is MEB.

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.

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Other records listing Mckinley Medical, LLC 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.

K060119MCKINLEY SATURATION CATHETER

Related Devices (Code: MEB)

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.

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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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