FDA 510(k)

Dr. Amplatz Micro Plug

K-Number: K182944 · 2019-04-17

Decision Date2019-04-17

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Dr. Amplatz Micro Plug is the device name listed in this FDA 510(k) record. The listed applicant is Ka Medical, LLC. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K182944. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dr. Amplatz Micro Plug?

Dr. Amplatz Micro Plug is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Ka Medical, LLC. The 510(k) number is K182944.

When did Dr. Amplatz Micro Plug receive FDA 510(k) clearance?

Dr. Amplatz Micro Plug received FDA 510(k) clearance on 2019-04-17, under 510(k) number K182944.

Who is the listed applicant for Dr. Amplatz Micro Plug?

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

What is the FDA product code for Dr. Amplatz Micro Plug?

The FDA product code for Dr. Amplatz Micro Plug is KRD.

Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, 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.