# K050217: Flower High-Density Mapping Catheter, 4-4-4 MM Electrode Spacing), (2-6-2 MM Electrode Spacing)

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Mar 30, 2005 after 58 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983171 (1999). 9 ancestors in all.
39 later devices descend from it; 2 cite it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002333: Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220, Biosense Webster, Inc. (2000) Summary page 1.
- K021232: Constellation Catheters, Model 8031M, Boston Scientific Corp (2002) Summary page 1.
- K011361: Desai Vectorcath Mapping Catheter, Desai Vectorcath Connector Cable, Catheffects, LLC (2001) Summary page 1.
- K982740: Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'S 301-803A, 301-803P, 301-803M, 301-813S, Cordis Webster, Inc. (1998) Summary page 1.

## Most influential descendants
- K120425: Pentaray Nav High-Density Mapping Catheter (2012), 34 descendants of its own
- 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

## Indications for use
The Biosense Webster Flower 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.

Source page: https://510kreport.com/device/K050217
Methodology: https://510kreport.com/methodology