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FDA 510(k)

MC3 Vascular Access Kit 21030

K-Number: K182914 · 2018-10-29

ApplicantMc3 Incorporated
Decision Date2018-10-29
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MC3 Vascular Access Kit 21030 is the device name listed in this FDA 510(k) record. The listed applicant is Mc3 Incorporated. It received FDA 510(k) clearance on 2018-10-29 under 510(k) number K182914. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MC3 Vascular Access Kit 21030?

MC3 Vascular Access Kit 21030 is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Mc3 Incorporated. The 510(k) number is K182914.

When did MC3 Vascular Access Kit 21030 receive FDA 510(k) clearance?

MC3 Vascular Access Kit 21030 received FDA 510(k) clearance on 2018-10-29, under 510(k) number K182914.

Who is the listed applicant for MC3 Vascular Access Kit 21030?

The FDA 510(k) record lists Mc3 Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MC3 Vascular Access Kit 21030?

The FDA product code for MC3 Vascular Access Kit 21030 is DRE.

Other records listing Mc3 Incorporated 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.

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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