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510(k) K221886

Device
Sublime Microcatheter
Applicant
Surmodics Inc.
510(k) number
K221886
Product code
DQY  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-14
Date received
2022-06-29
Regulation
870.1250
Classification name
Catheter, Percutaneous
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Holly Ramirez
Address
7905 Golden Triangle Dr. Suite #190 Eden Prairie MN US 55344 55344

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DQY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.2026-09-18
K260559NHanceITIMDS Operation B.V.2026-08-14
K262392APRO 35 Swift CatheterAlembic, LLC2026-08-12
K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC2026-07-29
K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC2026-07-29
K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott2026-07-02
K261631Amplatzer TorqVue Exchange SystemAbbott Medical2026-06-17
K260289Perfect-O Ostial Positioning CatheterBalosmark, Inc.2026-06-05
K260993Amplatzer TorqVue Delivery SystemAbbott2026-04-24
K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2026-04-10
K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80ABBOTT MEDICAL2026-03-13
K253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)Medtronic, Inc.2025-12-19
K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)ABBOTT MEDICAL2025-12-17
K252390Telescope Guide Extension CatheterMedtronic, Ireland2025-10-29
K250147CPS Locator 3D Delivery CatheterCenterpoint Systems2025-08-22

Legacy Summary#

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FDA Review#

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