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Access Vascular, Inc.

FDA 510(k) & PMA Approved Dispositivos — 9 products

Total de dispositivos9
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
510(k) K243458 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrLJS2025-08-01 Ver
510(k) K251212 Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)LJS2025-07-01 Ver
510(k) K244059 HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)FOZ2025-03-27 Ver
510(k) K243941 HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)LJS2025-01-17 Ver
510(k) K220772 HydroMID 4F Single Lumen Midline CatheterFOZ2022-12-07 Ver
510(k) K213550 HydroPICC 5F Dual Lumen CatheterLJS2022-05-04 Ver
510(k) K203069 HydroMIDFOZ2021-02-08 Ver
510(k) K193015 HydroPICC (PICC-142)LJS2020-02-20 Ver
510(k) K172885 HydroPICCLJS2018-02-20 Ver
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