510(k) · Cleared
ClearedMercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Pathways Corp. · MTD Catheter, Intracardiac Mapping, High-Density Array
Cleared on Jun 8, 1999 as substantially equivalent to K982540 (Cardiac Pathways Corp., 1999) after a 90-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 8, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- MTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982540 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK982540 Mercator Atrial High Density Array Catheter Models, 7005, 7006…Cardiac Pathways Corp. · 1999
- This deviceK990795 Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm…Cardiac Pathways Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982540 | Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator… | Cardiac Pathways Corp. | 1999 | — |
| 0 (this device) | K990795 | Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables | Cardiac Pathways Corp. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MTD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MTD device
- #1 K231312 PENTARAY® NAV ECO High Density Mapping…score 16.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982540 | Mercator Atrial High Density Array Catheter Models, 7005, 7006, 7007, Mercator Atrial…Summary page 1…nt. The Mercator High Density Array Catheter has been described previously in the 510(k) Summary and the Device Description section in the 510(k) submission file number K982540. There are three different EGM Adapter Cables for use with the Mercator Catheter. The distal end of the cable is identical in ea… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All MTD devicesMTD Catheter, Intracardiac Mapping, High-Density Array: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MTD
66in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTD
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTD
385in 2025
MAUDE reports naming product code MTD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 19 |
| 2011 | 0 | — | 0 | 14 |
| 2012 | 2 | — | 0 | 17 |
| 2013 | 2 | — | 0 | 30 |
| 2014 | 2 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 2 | 38 |
| 2018 | 1 | — | 0 | 49 |
| 2019 | 0 | — | 0 | 77 |
| 2020 | 4 | 169 | 0 | 87 |
| 2021 | 1 | — | 0 | 99 |
| 2022 | 2 | — | 0 | 145 |
| 2023 | 3 | 66 | 0 | 184 |
| 2024 | 2 | — | 0 | 378 |
| 2025 | 0 | — | 0 | 385 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Mercator Atrial High Density Array Catheter is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). When used in conjunction with electrogram recording equipment and stimulators, the system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative…
Read the full statement (123 words)
The Mercator Atrial High Density Array Catheter is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). When used in conjunction with electrogram recording equipment and stimulators, the system is used to record intracardiac electrogram (EGM) signals and to deliver pacing pulses for the purpose of diagnostic provocative stimulation during an electrophysiology procedure.
The Mercator Atrial High Density Array Catheter can be used with:
o the Cardiac Pathways’ Model 8100 Arrhythmia Mapping System and the Model 8300 Signal Acquisition Module in conjunction with a stimulator, and
o Cardiac Pathways’ EGM Adapter Cables (Models 2036, 2043, and 2044) in conjunction with intracardiac electrogram recording equipment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990795 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990795: Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990795
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026