Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit,
FDA 510(k) K982540 · Cardiac Pathways Corp.
510(k) numberK982540
Submission
- Device name
- Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit,
- Applicant
- Cardiac Pathways Corp.
Sunnyvale, CA, US - Received
- July 21, 1998
- Decision date
- January 27, 1999
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTD – Catheter, Intracardiac Mapping, High-Density Array
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
Other 510(k)s with product code MTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60)MTD · Special | Cortex, Inc. | 04/23/2026SE |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50)MTD · Traditional | Cortex, Inc. | 03/13/2026SE |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009)MTD · Traditional | Medtronic | 08/07/2024SE |
| K241372 | Advisor HD Grid X Mapping Catheter, Sensor EnabledMTD · Special | Abbott Medical | 07/09/2024SE |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…MTD · Special | Biosense Webster, Inc. | 07/10/2023SE |
| K223666 | Ablacath Mapping CatheterMTD · Traditional | Ablacon, Inc. | 03/17/2023SE |
| K230253 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Special | Biosense Webster, Inc. | 03/02/2023SE |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD · Traditional | Acutus Medical, Inc. | 06/21/2022SE |
| K211438 | OPTRELL Mapping Catheter with TRUEref TechnologyMTD · Traditional | Biosense Webster, Inc. | 03/18/2022SE |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping CatheterMTD · Traditional | Sterilmed Inc. (Johnson and Johnson) | 06/23/2021SE |
More from Sterilmed Inc. (Johnson and Johnson)
| 510(k) | Device | Decision |
|---|---|---|
| K992912 | Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac…DRF · Traditional | 03/08/2000SE |
| K990795 | Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter CablesMTD · Traditional | 06/08/1999SE |
| K983653 | Radii Diagnostic Electrophysiology Catheter, Model # 30411 B, C and DDRF · Traditional | 12/22/1998SE |
| K965066 | Arrhythmia Mapping System (8100/8300)DRF · Traditional | 08/11/1997SE |
Questions and answers
When was Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit, cleared by the FDA?
Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial High Density Array Deployment Kit, (K982540) received a 510(k) decision of Unknown on January 27, 1999, 190 days after the submission was received.
What is the product code of K982540?
The FDA product code is MTD – Catheter, Intracardiac Mapping, High-Density Array, a Class II (moderate risk) device regulated under 21 CFR 870.1220.