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

Clearance record K123378

SOLITAIRE 2 REVASCULARIZATION DEVICE · Micro Therapeutics Dba Ev3 Neurovascular · decided 2012-11-30 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Solitaire 2SFR2-6-20Micro Therapeutics, Inc.NRY POL00836462016392
SolitiareTMSFR2-4-15Micro Therapeutics, Inc.NRY POL00847536020702
SolitiareTMSFR2-4-20Micro Therapeutics, Inc.NRY POL00847536020719
SolitiareTMSFR2-6-20Micro Therapeutics, Inc.NRY POL00847536020726
Solitaire 2SFR2-4-20Micro Therapeutics, Inc.NRY POL00836462016385
SolitiareTMSFR2-6-30Micro Therapeutics, Inc.NRY POL00847536020733
Solitaire 2SFR2-4-15Micro Therapeutics, Inc.NRY00836462016378
Solitaire 2SFR2-6-30Micro Therapeutics, Inc.NRY POL00836462016408