Medical Device Manufacturer · US , Eden Prairie , MN

Surmodics,Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2018

Recent clearances: Pounce(TM) Sheath, Pounce XL Thrombectomy System (PTS-1011-7F135), Microcatheter

11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Surmodics,Inc. Cardiovascular ✕

11 devices
1-11 of 11
Cleared Sep 24, 2025
Pounce(TM) Sheath
K252227 · DYB
Cardiovascular · 70d
Cleared Sep 11, 2024
Pounce XL Thrombectomy System (PTS-1011-7F135)
K241362 · QEW
Cardiovascular · 120d
Cleared Sep 29, 2023
Microcatheter
K232647 · DQY
Cardiovascular · 29d
Cleared Sep 07, 2023
Pounce™ Sheath
K231828 · DYB
Cardiovascular · 78d
Cleared Jun 12, 2023
Pounce™ Thrombectomy System
K231022 · QEW
Cardiovascular · 63d
Cleared Oct 14, 2022
Sublime Microcatheter
K221886 · DQY
Cardiovascular · 107d
Cleared Mar 23, 2022
Pounce Thrombectomy System
K220501 · QEW
Cardiovascular · 29d
Cleared Jul 30, 2021
Pounce Thrombectomy System
K211492 · QEW
Cardiovascular · 78d
Cleared Sep 21, 2020
Pounce Thrombus Retrieval System
K192814 · QEW
Cardiovascular · 356d
Cleared Apr 18, 2019
Guide Sheath
K190644 · DYB
Cardiovascular · 36d
Cleared Jan 12, 2018
Microcatheter
K173560 · DQY
Cardiovascular · 56d
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