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FDA 510(k)

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

K-Number: K181051 · 2018-06-22

ApplicantShape Memory Medical
Decision Date2018-06-22
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is a medical device manufactured by Shape Memory Medical. It received FDA 510(k) clearance on 2018-06-22 under approval number K181051. 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 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm?

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Shape Memory Medical. The 510(k) number is K181051.

When was IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm approved by the FDA?

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm received FDA 510(k) clearance on 2018-06-22, under approval number K181051.

What company makes IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm?

IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is manufactured by Shape Memory Medical.

What is the FDA product code for IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm?

The FDA product code for IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm is KRD.

Other Devices by Shape Memory Medical

K182390IMPEDE-FX Embolization Plug

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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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