Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DQY — Predicate Candidate Screening
893 FDA 510(k) clearances under this product code; the 50 most recent screened below.
85 daysmedian FDA review time
216 days90th percentile
893clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 | 62 | 0 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 | 28 | 0 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP C | Abbott | 2026-07-02 | 30 | 0 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 | 30 | 0 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 | 127 | 0 |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 | 29 | 0 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 | 192 | 0 |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F | ABBOTT MEDICAL | 2026-03-13 | 28 | 0 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery Syste | Medtronic, Inc. | 2025-12-19 | 80 | 0 |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 | 138 | 0 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 | 90 | 0 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 | 213 | 0 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 | 120 | 0 |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 | 90 | 0 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 | 100 | 0 |
| K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025-06-25 | 268 | 0 |
| K250492 | FlexiGo 3D Delivery Catheter | CenterPoint Systems, LLC | 2025-06-18 | 118 | 0 |
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | Bard Peripheral Vascular, Inc. | 2025-06-17 | 144 | 0 |
| K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025-06-02 | 109 | 0 |
| K243757 | Shockwave CS Guide Catheter | Shockwave Medical, Inc. | 2025-05-02 | 147 | 0 |
| K251014 | APRO 45 Catheter | Alembic, LLC | 2025-05-01 | 29 | 0 |
| K250962 | APRO 55 Intermediate Catheter | Alembic, LLC | 2025-04-29 | 29 | 0 |
| K250426 | Amulet™ Steerable Delivery Sheath | ABBOTT MEDICAL | 2025-04-25 | 70 | 0 |
| K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | Imds Operations B.V. | 2025-04-17 | 253 | 0 |
| K243691 | LiquID .051 LP Guide Catheter Extension | Seigla Medical, Inc. | 2025-04-04 | 129 | 0 |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Del | Medtronic, Inc. | 2025-03-27 | 30 | 0 |
| K243436 | Seclusion Catheter | Basis Medical | 2025-02-28 | 115 | 0 |
| K242873 | Ventrax™ Delivery System | Merit Medical Systems, Inc. | 2025-01-15 | 114 | 0 |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Micr | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 | 130 | 0 |
| K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G | ABBOTT MEDICAL | 2024-12-31 | 85 | 0 |
| K242644 | SENDERO MAX Delivery Catheter | Okami Medical, Inc. | 2024-12-20 | 108 | 0 |
| K240885 | Shadow Catheter | Simpson Interventions, Inc. | 2024-12-19 | 262 | 0 |
| K243180 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2024-12-04 | 65 | 0 |
| K242276 | CrossFAST™ Integrated Microcatheter Guide Extension System ( | Vantis Vascular, Inc. | 2024-09-30 | 60 | 0 |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-4517 | Biotronik, Inc. | 2024-09-12 | 174 | 0 |
| K241611 | ShapeIT (SI014135) | Imds Operations B.V. | 2024-09-03 | 90 | 0 |
| K241538 | TriClip Steerable Guide Catheter | ABBOTT MEDICAL | 2024-08-26 | 88 | 0 |
| K233637 | Cordis BRITECROSS Support Catheter | Cordis US Corp | 2024-06-28 | 228 | 0 |
| K241158 | ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus | Asahi Intecc Co., Ltd. | 2024-06-25 | 60 | 0 |
| K241177 | React 71 Catheter | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | 2024-05-28 | 29 | 0 |
| K234115 | APRO 55 Catheter | Alembic, LLC | 2024-03-15 | 79 | 0 |
| K240384 | SENDERO Microcatheter | Okami Medical, Inc. | 2024-03-08 | 29 | 0 |
| K233350 | SINC Support Catheter | Reflow Medical, Inc. | 2024-02-08 | 132 | 0 |
| K240018 | WATCHMAN TruSteer Access System (M635TU90050) | Boston Scientific Corporation | 2024-02-01 | 30 | 1 |
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 | 219 | 0 |
| K233858 | TriSalus TriGuideTM Guiding Catheter | Trisalus Life Sciences | 2023-12-27 | 22 | 0 |
| K231600 | SENDERO Microcatheter | Okami Medical, Inc. | 2023-11-17 | 169 | 0 |
| K231629 | 091 Balloon Guide Catheter | Eosolutions, Corp. | 2023-10-31 | 148 | 0 |
| K232437 | Paragon 8F Balloon Guide Catheter | Wallaby Medical | 2023-10-13 | 60 | 0 |
| K232647 | Microcatheter | Surmodics,Inc. | 2023-09-29 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda