# K120425: Pentaray Nav High-Density Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: May 24, 2012 after 101 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983171 (1999). 10 ancestors in all.
34 later devices descend from it; 2 cite it directly.
1 of 45 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050217: Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing), Biosense Webster, Inc. (2005) Summary page 1.

## Most influential descendants
- K172393: Advisor HD Grid Mapping Catheter, Sensor Enabled (2018), 21 descendants of its own
- K202066: EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled (2020), 17 descendants of its own
- K212061: EnSite X EP System (2021), 13 descendants of its own
- K213364: EnSite X EP System (2021), 12 descendants of its own
- K221213: EnSite X EP System (2022), 11 descendants of its own

## Recalls of this device
- Apr 22, 2020 · Class II · Z-2371-2020: Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.
- May 17, 2017 · Class II · Z-0211-2018: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
- May 17, 2017 · Class II · Z-0212-2018: Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.
- Apr 14, 2016 · Class II · Z-1590-2016: Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthe
- Feb 20, 2014 · Class II · Z-1176-2014: Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster is expanding the recall on 5/1/14 to inclu

## Indications for use
The Biosense Webster PENTARAY® NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV High-Density Mapping Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to Version 3.0.)

Source page: https://510kreport.com/device/K120425
Methodology: https://510kreport.com/methodology