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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K153071

Solitaire Platinum Revascularization Device · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · decided 2015-12-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SolitaireTMSFR3-4-20-10Micro Therapeutics, Inc.NRY POL00847536020528
SolitaireTMSFR3-4-40-10Micro Therapeutics, Inc.NRY00847536020535
Solitaire™SFR3-4-40-10Micro Therapeutics, Inc.NRY POL00847536033948
SolitaireTMSFR3-6-20-10Micro Therapeutics, Inc.NRY POL00847536020542
Solitaire™SFR3-4-20-10Micro Therapeutics, Inc.NRY00847536033931
Solitaire™SFR3-6-20-10Micro Therapeutics, Inc.NRY00847536033955