DQY — Catheter, Percutaneous Class II

FDA Device Classification

FDA product code DQY covers "Catheter, Percutaneous", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DQY
Device Class
Class II
Regulation Number
870.1250
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K262817Vantis VascularCrossFAST Integrated Microcatheter Advanced Delivery SystemSep 18, 2026
K260559Imds OperationNHanceITAug 14, 2026
K262392AlembicAPRO 35 Swift CatheterAug 12, 2026
K262240Centerpoint SystemsSSPC NXT Delivery CatheterJul 29, 2026
K261766Centerpoint SystemsCPS Locator 3D Plus Delivery CatheterJul 29, 2026
K261825AbbottAmplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterJul 2, 2026
K261631Abbott MedicalAmplatzer TorqVue Exchange SystemJun 17, 2026
K260289BalosmarkPerfect-O Ostial Positioning CatheterJun 5, 2026
K260993AbbottAmplatzer TorqVue Delivery SystemApr 24, 2026
K253361Orbusneich Medical (Shenzhen) CoTeleport Glide MicrocatheterApr 10, 2026
K260499Abbott MedicalAmplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-Mar 13, 2026
K253409MedtronicC320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320Dec 19, 2025
K252417Abbott MedicalAmplatzer Piccolo™ Delivery System (9-PDS-04F-045)Dec 17, 2025
K252390Medtronic, IrelandTelescope Guide Extension CatheterOct 29, 2025
K250147Centerpoint SystemsCPS Locator 3D Delivery CatheterAug 22, 2025
K251277Reflow MedicalCoraForce Microcatheter, CoraFlex MicrocatheterAug 22, 2025
K250972PendracarePrimum Hydrophilic Guiding CatheterJun 29, 2025
K250828Centerpoint SystemsCPS Locator 3D Plus Delivery CatheterJun 27, 2025
K243184Strait Access Technologies HoldingsSAT CenterFlow Molding Balloon Catheter (IN20-00313)Jun 25, 2025
K250492Centerpoint SystemsFlexiGo 3D Delivery CatheterJun 18, 2025