Chrysalis Intelligence · Sponsors · Surmodics,Inc.

Surmodics,Inc.

Eden Prairie, MN, US · 9 510(k) clearances · 7 PMAs

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Total clearances
9
2020-09-21 → 2025-09-24
Last 12 months
1
Product codes
3
Most recent
2025-09-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QEW Peripheral Mechanical Thrombectomy With Aspiration Class II Cardiovascular 5 2024-09-11
DYB Introducer, Catheter Class II Cardiovascular 2 2025-09-24
DQY — — — 2 2023-09-29
Class III

PMA approvals (7)

Total PMA records
7
Originals + supplements
Distinct product codes
1
First decision
2023-06-16
Most recent
2025-06-06
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2025-06-06 P210025-S006 SurVeil Drug-Coated Balloon Normal 180 Day Track No User Fee ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
2024-12-20 P210025-S005 Surmodics SurVeil™ Drug-Coated Balloon 30-Day Notice ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
2024-08-20 P210025-S004 Surmodics SurVeil™ Drug-Coated Balloon 30-Day Notice ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
2024-07-02 P210025-S003 Surmodics SurVeil Drug-Coated Balloon Real-Time Process ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
2024-02-29 P210025-S002 Surmodics SurVeil™ Drug-Coated Balloon 30-Day Notice ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
2024-01-03 P210025-S001 Surmodics SurVeil™ Drug-Coated Balloon 30-Day Notice ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
2023-06-16 P210025 SurVeil Drug-Coated Balloon Original ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown
Filings

All 510(k) clearances (9)

Date K-number Device Code Class Specialty
2025-09-24 K252227 Pounce(TM) Sheath DYB Class II Cardiovascular
2024-09-11 K241362 Pounce XL Thrombectomy System (PTS-1011-7F135) QEW Class II Cardiovascular
2023-09-29 K232647 Microcatheter DQY — —
2023-09-07 K231828 Pounce™ Sheath DYB Class II Cardiovascular
2023-06-12 K231022 Pounce™ Thrombectomy System QEW Class II Cardiovascular
2022-10-14 K221886 Sublime Microcatheter DQY — —
2022-03-23 K220501 Pounce Thrombectomy System QEW Class II Cardiovascular
2021-07-30 K211492 Pounce Thrombectomy System QEW Class II Cardiovascular
2020-09-21 K192814 Pounce Thrombus Retrieval System QEW Class II Cardiovascular
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence