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Surmodics,Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories4
Latest Approval2025-09-24
TypeNumberDevice NameCodeDate
510(k) K252227 Pounce(TM) Sheath DYB 2025-09-24 View
510(k) K241362 Pounce XL Thrombectomy System (PTS-1011-7F135) QEW 2024-09-11 View
510(k) K232647 Microcatheter DQY 2023-09-29 View
510(k) K231828 Pounce™ Sheath DYB 2023-09-07 View
PMA P210025 Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU 2023-06-16 View
510(k) K231022 Pounce™ Thrombectomy System QEW 2023-06-12 View
510(k) K221886 Sublime Microcatheter DQY 2022-10-14 View
510(k) K220501 Pounce Thrombectomy System QEW 2022-03-23 View
510(k) K211492 Pounce Thrombectomy System QEW 2021-07-30 View
510(k) K192814 Pounce Thrombus Retrieval System QEW 2020-09-21 View
510(k) K190644 Guide Sheath DYB 2019-04-18 View
510(k) K173560 Microcatheter DQY 2018-01-12 View
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