Abbott
FDA 510(k) & PMA Approved Devices — 14 products
Total Devices14
Categories8
Latest FDA decision2026-07-02
SEC Filings: 1 filings on record. Latest: 8-K (2026-07-16). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | DQY | 2026-07-02 | View |
| PMA | P170038 | Ventricular (assist) bypass | DSQ | 2026-05-05 | View |
| 510(k) | K260993 | Amplatzer TorqVue Delivery System | DQY | 2026-04-24 | View |
| 510(k) | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | MXD | 2025-09-17 | View |
| 510(k) | K233655 | Lingo Glucose System | SAF | 2024-05-29 | View |
| 510(k) | K222297 | CentriMag Pre-connected Pack | DTZ | 2022-12-01 | View |
| 510(k) | K221213 | EnSite X EP System | DQK | 2022-08-18 | View |
| 510(k) | K212061 | EnSite X EP System | DQK | 2021-10-22 | View |
| 510(k) | K210392 | WorkMate Claris System | DQK | 2021-03-11 | View |
| 510(k) | K192593 | Confirm Rx Insertable Cardiac Monitor | MXC | 2019-10-18 | View |
| 510(k) | K190167 | MitraClip G4 Steerable Guide Catheter | DRA | 2019-05-29 | View |
| 510(k) | K182981 | Confirm Rx Insertable Cardiac Monitor | MXC | 2019-03-29 | View |
| 510(k) | K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | DQK | 2018-12-12 | View |
| 510(k) | K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | DQK | 2018-10-19 | View |
No matching devices.
Related Clinical Trials
NCT00698607Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTingCOMPLETEDNCT01516723Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary OcclusionsCOMPLETEDNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT04124341PCS in Severe Treatment Resistant DepressionRECRUITINGNCT04349657A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery EndarterectomyACTIVE_NOT_RECRUITINGNCT04483089An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device (bRIGHT)ACTIVE_NOT_RECRUITINGNCT04754217Valved Graft PMCF StudyRECRUITINGNCT04761120Annuloplasty Rings and Band Post-Market Clinical Follow-Up StudyRECRUITINGNCT05650411Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM)RECRUITINGNCT06083038Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating AlpelisibCOMPLETED