FDA 510(k)

IMPEDE-FX Embolization Plug

K-Number: K182390 · 2019-05-23

Decision Date2019-05-23

Product CodeKRD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMPEDE-FX Embolization Plug is a medical device manufactured by Shape Memory Medical. It received FDA 510(k) clearance on 2019-05-23 under approval number K182390. 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-FX Embolization Plug?

IMPEDE-FX Embolization Plug is a medical device that received FDA 510(k) clearance on 2019-05-23. It is manufactured by Shape Memory Medical. The 510(k) number is K182390.

When was IMPEDE-FX Embolization Plug approved by the FDA?

IMPEDE-FX Embolization Plug received FDA 510(k) clearance on 2019-05-23, under approval number K182390.

What company makes IMPEDE-FX Embolization Plug?

IMPEDE-FX Embolization Plug is manufactured by Shape Memory Medical.

What is the FDA product code for IMPEDE-FX Embolization Plug?

The FDA product code for IMPEDE-FX Embolization Plug is KRD.

Other Devices by Shape Memory Medical

K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

Related Devices (Code: KRD)

K162373LC Bead LUMIBiocompatibles UK Limited K160219Hilal Embolization MicroCoilsCook Incorporated K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated K150876Bead BlockBiocompatibles UK , Ltd. K171946Gel-BeadVascular Solutions, Inc. K172372QuadraSphere MicrospheresBiosphere Medical, S.A.

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.