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FDA 510(k)

VACULINK, MODEL VCL 3000

K-Number: K043614 · 2005-04-14

ApplicantMedevco, Inc.
Decision Date2005-04-14
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VACULINK, MODEL VCL 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Medevco, Inc.. It received FDA 510(k) clearance on 2005-04-14 under 510(k) number K043614. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACULINK, MODEL VCL 3000?

VACULINK, MODEL VCL 3000 is a medical device that received FDA 510(k) clearance on 2005-04-14. The listed applicant is Medevco, Inc.. The 510(k) number is K043614.

When did VACULINK, MODEL VCL 3000 receive FDA 510(k) clearance?

VACULINK, MODEL VCL 3000 received FDA 510(k) clearance on 2005-04-14, under 510(k) number K043614.

Who is the listed applicant for VACULINK, MODEL VCL 3000?

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

What is the FDA product code for VACULINK, MODEL VCL 3000?

The FDA product code for VACULINK, MODEL VCL 3000 is HDB.

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Related Devices (Code: HDB)

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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