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Surmodics,Inc.

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

Total Devices12
Categories4
Latest FDA decision2025-09-24
TypeNumberDevice NameCodeDateActions
510(k) K252227 Pounce(TM) SheathDYB2025-09-24 View
PMA P210025 Drug-Eluting Peripheral Transluminal Angioplasty CatheterONU2025-06-06 View
510(k) K241362 Pounce XL Thrombectomy System (PTS-1011-7F135)QEW2024-09-11 View
510(k) K232647 MicrocatheterDQY2023-09-29 View
510(k) K231828 Pounce™ SheathDYB2023-09-07 View
510(k) K231022 Pounce™ Thrombectomy SystemQEW2023-06-12 View
510(k) K221886 Sublime MicrocatheterDQY2022-10-14 View
510(k) K220501 Pounce Thrombectomy SystemQEW2022-03-23 View
510(k) K211492 Pounce Thrombectomy SystemQEW2021-07-30 View
510(k) K192814 Pounce Thrombus Retrieval SystemQEW2020-09-21 View
510(k) K190644 Guide SheathDYB2019-04-18 View
510(k) K173560 MicrocatheterDQY2018-01-12 View
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