510(k) · Cleared
Recalled · Class II · 2013Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Dec 5, 2011 as substantially equivalent to K081258 (Biosense Webster, Inc., 2009) and 1 other predicate after a 34-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2011
- Review
- 34 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002333 (2000). 5 ancestors in all, the oldest K954390 (1995). 4 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
- 3 generations backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
- 2 generations backK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
- 1 generation backK093376 Lasso Nav CatheterBiosense Webster, Inc. · 2010
- This deviceK113213 Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter…Biosense Webster, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK211327 Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…CathRx, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK153006 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable…Sterilmed, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK153153 Reprocessed Electrophysiology CatheterInnovative Health, LLC · 2016
- Descendant · cites it directly · 0 of its ownK130602 Lasso Nav Duo Loop CatheterBiosense Webster, Inc. · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…CathRx, Ltd. · 2022 · cites it directly0descendants
- K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc. · 2016 · cites it directly0descendants
- K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC · 2016 · cites it directly0descendants
- K130602Lasso Nav Duo Loop CatheterBiosense Webster, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | 2 |
| −3 | K031161 | Variable Lasso 2515 Circular Mapping Catheter | Biosense Webster, Inc. | 2003 | 2 |
| −2 | K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02 | Biosense Webster, Inc. | 2009 | — |
| −1 | K093376 | Lasso Nav Catheter | Biosense Webster, Inc. | 2010 | — |
| 0 (this device) | K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From… | Biosense Webster, Inc. | 2011 | — |
| +1 | K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed… | CathRx, Ltd. | 2022 | — |
| +1 | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology… | Sterilmed, Inc. | 2016 | — |
| +1 | K153153 | Reprocessed Electrophysiology Catheter | Innovative Health, LLC | 2016 | — |
| +1 | K130602 | Lasso Nav Duo Loop Catheter | Biosense Webster, Inc. | 2013 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 1 | 0 |
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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Summary page 1…(21 CER 870.1220, Product Code DRF) Predicate Devices: LASSO® 2515 NAV Variable Catheter 510(k): K081258 LASSO®NAV Catheter 510(k): K093376 Manufacturer:… | 2009 |
| * | K093376 | Lasso Nav CatheterSummary page 1…Catheter 510(k): K081258 LASSO®NAV Catheter 510(k): K093376 Manufacturer: Biosense Webster, Inc. 3333 Diamond Canyon Road… | 2010 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology… | 2022 | 0 |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter | 2016 | 0 |
| K153153 | Reprocessed Electrophysiology Catheter | 2016 | 0 |
| K130602 | Lasso Nav Duo Loop Catheter | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2013 | Class II | Z-1617-2013 | Use error | Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K211327 (CathRx, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K081258.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
LASSO® 2515 NAV eco Variable Catheter The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. The LASSO® 2515 NAV eco Variable Catheter provides location information when used with compatible CARTO® 3 EP Navigation Systems. (This catheter is not…
Read the full statement (154 words)
LASSO® 2515 NAV eco Variable Catheter
The LASSO® 2515 NAV eco Variable Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® 2515 NAV eco Variable 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 2.3.)
LASSO® NAV eco Catheter
The LASSO® NAV eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® NAV eco 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 2.3.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113213: Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113213
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