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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K170997
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Product Description
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CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guidin... 2 03/13/2024 Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 27... 2 04/01/2023 Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 279... 2 04/01/2023 Biosense Webster, Inc.
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovasc... 2 09/02/2022 Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Onl... 2 03/22/2021 Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Onl... 2 03/22/2021 Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx On... 2 03/22/2021 Biosense Webster, Inc.
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