Product code MTD— Cardiovascular

FDA has cleared 34 devices under product code MTD between 1999 and 2026, filed by 16 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20262 clearances
• 20242 clearances
• 20233 clearances
• 20222 clearances
• 20211 clearance
• 20204 clearances
• 20181 clearance
• 20172 clearances
• 20161 clearance
• 20142 clearances
• 20132 clearances
• 20122 clearances
• 20051 clearance
• 20021 clearance
• 20012 clearances

• Biosense Webster, Inc.8 clearances
• Boston Scientific Corp5 clearances
• Acutus Medical, Inc.3 clearances
• Topera, Inc.2 clearances
• Endocardial Solutions, Inc.2 clearances
• Cortex, Inc.2 clearances
• Cardiac Pathways Corp.2 clearances
• Abbott Electrophysiology2 clearances
• Sterilmed Inc. (Johnson and Johnson)1 clearance
• St. Jude Medical, Inc.1 clearance

Death

22

Injury

376

Malfunction

986

Total

1,384

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K261012 — OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.·2026-04-23
• K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.·2026-03-13
• K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic·2024-08-07
• K241372 — Advisor HD Grid X Mapping Catheter, Sensor EnabledABBOTT MEDICAL·2024-07-09
• K231312 — PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.·2023-07-10
• K223666 — Ablacath Mapping CatheterAblacon, Inc.·2023-03-17
• K230253 — OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster, Inc.·2023-03-02
• K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009Acutus Medical, Inc.·2022-06-21
• K211438 — OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster, Inc.·2022-03-18
• K201806 — Reprocessed PentaRay Nav eco High-Density Mapping CatheterSterilmed Inc. (Johnson and Johnson)·2021-06-23
• K201341 — AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.·2020-09-15
• K200212 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC·2020-09-03
• K201750 — Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.·2020-08-06
• K193237 — Carto Octaray Mapping Catheter with Trueref TechnologyBiosense Webster, Inc.·2020-07-31
• K172393 — Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc.·2018-04-23
• K170819 — AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.·2017-10-16
• K163709 — FIRMap CatheterAbbott Electrophysiology·2017-02-28
• K153093 — FIRMap CatheterAbbott Electrophysiology·2016-04-07
• K142182 — FRIMAP ADAPTER CONNECTOR (MAC)Topera, Inc.·2014-09-09
• K140733 — CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETERBoston Scientific Corporation·2014-04-28
• K130827 — FIRMAP CATHETERTopera, Inc.·2013-10-31
• K123837 — PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc.·2013-03-05
• K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETERBiosense Webster, Inc.·2012-05-24
• K121006 — ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETERSt Jude Medical·2012-05-03
• K050217 — FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)Biosense Webster, Inc.·2005-03-30
• K021232 — CONSTELLATION CATHETERS, MODEL 8031MBoston Scientific Corp·2002-05-16
• K012926 — MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000Endocardial Solutions, Inc.·2001-09-28
• K003782 — CONSTELLATION CATHETER, MODEL 8031Boston Scientific Corp·2001-02-14
• K000277 — CONSTELLATION CATHETERSBoston Scientific Corp·2000-09-26
• K992777 — CONSTELLATION CATHETERS, MODEL 8039Boston Scientific Corp·1999-11-12
• K990795 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLESCardiac Pathways Corp.·1999-06-08
• K983456 — ENSITE 3000 SYSTEMEndocardial Solutions, Inc.·1999-04-21
• K983171 — CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEMBoston Scientific Corp·1999-03-11
• K982540 — MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT,Cardiac Pathways Corp.·1999-01-27