DQY — Catheter, Percutaneous Class II
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261825 | abbott | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | July 2, 2026 |
| K261631 | abbott medical | Amplatzer TorqVue Exchange System | June 17, 2026 |
| K260289 | balosmark | Perfect-O Ostial Positioning Catheter | June 5, 2026 |
| K260993 | abbott | Amplatzer TorqVue Delivery System | April 24, 2026 |
| K253361 | orbusneich medical (shenzhen) co | Teleport Glide Microcatheter | April 10, 2026 |
| K260499 | abbott medical | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- | March 13, 2026 |
| K253409 | medtronic | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 | December 19, 2025 |
| K252417 | abbott medical | Amplatzer Piccolo Delivery System (9-PDS-04F-045) | December 17, 2025 |
| K252390 | medtronic, ireland | Telescope Guide Extension Catheter | October 29, 2025 |
| K251277 | reflow medical | CoraForce Microcatheter, CoraFlex Microcatheter | August 22, 2025 |
| K250147 | centerpoint systems | CPS Locator 3D Delivery Catheter | August 22, 2025 |
| K250972 | pendracare | Primum Hydrophilic Guiding Catheter | June 29, 2025 |
| K250828 | centerpoint systems | CPS Locator 3D Plus Delivery Catheter | June 27, 2025 |
| K243184 | strait access technologies holdings | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | June 25, 2025 |
| K250492 | centerpoint systems | FlexiGo 3D Delivery Catheter | June 18, 2025 |
| K250219 | bard peripheral vascular | Dorado PTA Balloon Dilatation Catheter | June 17, 2025 |
| K250410 | w. l. gore and associates | GORE® Tri-Lobe Balloon Catheter | June 2, 2025 |
| K243757 | shockwave medical | Shockwave CS Guide Catheter | May 2, 2025 |
| K251014 | alembic | APRO 45 Catheter | May 1, 2025 |
| K250962 | alembic | APRO 55 Intermediate Catheter | April 29, 2025 |