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

0

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	Catheter, Percutaneous	Class II	Cardiovascular	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

Date	PMA #	Trade name	Type	Code	Device name	Specialty
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	Class II	Cardiovascular
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	Class II	Cardiovascular
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