FDA 510(k) Premarket Notification K241362: Pounce XL Thrombectomy System (PTS-1011-7F135)

Submission Details & Decision

Normalized public record details for 510(k) notification K241362.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K241362

Applicant / Sponsor

Surmodics,Inc.

Device Name

Pounce XL Thrombectomy System (PTS-1011-7F135)

Product Code

QEW

Decision Date

2024-09-11

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-05-14

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
AngioDynamics, Inc. Registration: 1000523114 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
ANDERSEN SCIENTIFIC, INC. Registration: 1064858 View Registration
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center Registration: 1225687 View Registration
ANGIODYNAMICS, INC. Registration: 1319211 View Registration
MEDICAL MURRAY, INC. Registration: 1424778 View Registration
ARGON MEDICAL DEVICES INC. Registration: 1625425 View Registration
MedXL Registration: 1644312 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
BARD PERIPHERAL VASCULAR, INC. Registration: 2020394 View Registration
Sterigenics U.S., LLC Registration: 2022435 View Registration
Isomedix Operations, Inc. Registration: 2030624 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 2134265 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
LYNX Medical NJ Registration: 2244478 View Registration
Boston Scientific Corporation Registration: 2648729 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
Excel Medical Products, Inc. Registration: 3004198398 View Registration
Plexus Manufacturing Sdn. Bhd. Registration: 3004593495 View Registration
Cirtec Medical Registration: 3004737415 View Registration
SUPERCOMAL MEDICAL PRODUCTS, SDN BHD Registration: 3004832480 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3004859241 View Registration
ARMOR PLAST LTD Registration: 3005160949 View Registration
PENUMBRA, INC. Registration: 3005168196 View Registration
MEDISTRI SA Registration: 3006946276 View Registration
Boston Scientific Corporation Registration: 3007695959 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
STRAUB MEDICAL AG Registration: 3008439199 View Registration
PDV MedTech Registration: 3008514120 View Registration
Verge Medical Inc. Registration: 3008700817 View Registration
Medtronic Distribution Center Registration: 3009380063 View Registration
SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD. Registration: 3010034260 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
CULVER TOOL & ENGINEERING Registration: 3010047454 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
Synergy Health AST, SRL Registration: 3010273872 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
CONTEGO MEDICAL, INC Registration: 3011471056 View Registration
Merit Maquiladora Mexico, S. DE R.L. DE C.V. Registration: 3011642792 View Registration
Penumbra Inc. Registration: 3013758550 View Registration
Eurofins Infinity Laboratory Group Inc. Registration: 3013944123 View Registration
VESALIO Registration: 3014498720 View Registration
IMPERATIVE CARE INC. Registration: 3014590708 View Registration
SURMODICS, INC. Registration: 3014687026 View Registration
VETEX MEDICAL LIMITED Registration: 3014787927 View Registration
Penumbra Inc. Registration: 3015615738 View Registration
AUSA Medical Device Pvt Ltd Registration: 3015924373 View Registration
Penumbra Inc. Registration: 3016591327 View Registration
CATHX MEDICAL INC Registration: 3016704395 View Registration
Expanse Medical Inc. Registration: 3017823876 View Registration
CENTERPIECE S. DE R.L DE C.V (sterilization site) Registration: 3019807891 View Registration
Innova Vascular, Inc. Registration: 3020256033 View Registration
Inari Medical, Inc. Registration: 3020347218 View Registration
CONTEGO MEDICAL, INC Registration: 3025465918 View Registration
ENDOVASCULAR ENGINEERING, INC. Registration: 3026567963 View Registration
CATHX MEDICAL INC Registration: 3027226463 View Registration
ICHOR VASCULAR INC Registration: 3029444898 View Registration
INTERVENE INC Registration: 3030481118 View Registration
INQUIS MEDICAL, INC. Registration: 3031823122 View Registration
Nextern Registration: 3031976597 View Registration
PROTEXA ENDOVASCULAR Registration: 3034619061 View Registration
Inari Medical, Costa Rica S.A. Registration: 3040801290 View Registration
MEDTRONIC IRELAND Registration: 9612164 View Registration
Boston Scientific Limited Registration: 9616684 View Registration
Boston Scientific Limited Registration: 9681260 View Registration

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