FDA.reportPublic FDA data

SURMODICS, INC.

Matched from indexed company URL: Surmodics,Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30013748203001374820SURMODICS, INC.1N2026-01-019924 W 74th St EDEN PRAIRIE MN US 55344
30146870263014687026SURMODICS, INC.1N2026-01-017905 Golden Triangle Drive Suite 190 Eden Prairie MN US 55344

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
647672073416949P210025SurVeil Drug-Coated BalloonONU2023-06-16
2937052073416949P210025SurVeil Drug-Coated BalloonONU2023-06-16
2937051563924717K252227Pounce(TM) SheathDYB2025-09-24
2937051625567939K241362Pounce XL Thrombectomy System (PTS-1011-7F135)QEW2024-09-11
2937051321288635K231828Pounce™ SheathDYB2023-09-07
2937051888982142K231022Pounce™ Thrombectomy SystemQEW2023-06-12
2937051481829027K221886Sublime MicrocatheterDQY2022-10-14
2937051731995948K220501Pounce Thrombectomy SystemQEW2022-03-23
2937051588808311K211492Pounce Thrombectomy SystemQEW2021-07-30
647671588808311K211492Pounce Thrombectomy SystemQEW2021-07-30
2937051593834120K211044Sublime Radial Access 018 RX Dilatation CatheterLIT2021-06-16
2937051862682277K201705ReVene Thrombectomy CatheterQEW2020-12-22
2937051339325433K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation CatheterLIT2020-05-14
2937052050627442K192814Pounce Thrombus Retrieval SystemQEW2020-09-21
647672050627442K192814Pounce Thrombus Retrieval SystemQEW2020-09-21
647671068522141K190644Guide SheathDYB2019-04-18
2937051068522141K190644Guide SheathDYB2019-04-18
2937051309487525K173560MicrocatheterDQY2018-01-12
647671309487525K173560MicrocatheterDQY2018-01-12
647671748128203K172000ClearLumen II Peripheral Thrombectomy SystemQEZ2017-10-24
647671337684078K163051ClearLumen II Peripheral Thrombectomy SystemQEZ2017-02-21
647671662519974K150292Chocolate PTCA Balloon CatheterLOX2015-04-09
647671858481674K131914OFFROAD RE-ENTRY CATHETER SYSTEMPDU2013-10-31
647671986062881K122070CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 GLIT2012-08-15
647671978871504K121681GLIDER PTCA BALLOON CATHETERLOX2012-06-26
647671617270519K121402CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' GLIT2012-06-08
647671010402337K120677CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)LIT2012-03-15
647671075034795K111738CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018)DQY2011-12-14
647671801532331K111544GLIDER PTCA BALLOON CATHETERLOX2012-03-02
647671511007154K103534GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIREDQY2011-01-05
647671302442070K101062GLIDER PTA BALLOON CATHETERLIT2010-05-12
647671185222431K094019GLIDER PTA BALLOON CATHETERDQY2010-02-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEW92024-09-11
DQY72022-10-14
LIT62021-06-16
DYB42025-09-24
LOX32015-04-09
QEZ22017-10-24
PDU12013-10-31

PMN#

GUDID#

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