510(k) · Cleared
ClearedLasso Nav Catheter
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 Jun 18, 2010 as substantially equivalent to K002333 (Biosense Webster, Inc., 2000) and 1 other predicate after a 232-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it.
- Decided
- Jun 18, 2010
- Review
- 232 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002333 (2000). 4 ancestors in all, the oldest K954390 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002333 Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model…Biosense Webster, Inc. · 2000 · Recalled
- 2 generations backK031161 Variable Lasso 2515 Circular Mapping CatheterBiosense Webster, Inc. · 2003 · Recalled
- 1 generation backK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
- This deviceK093376 Lasso Nav CatheterBiosense Webster, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK113213 Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter…Biosense Webster, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK211327 Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed…CathRx, Ltd. · 2022
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK130602 Lasso Nav Duo Loop CatheterBiosense Webster, Inc. · 2013 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K113213Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2Biosense Webster, Inc. · 2011 · cites it directly4descendants
- K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology…CathRx, Ltd. · 2022 · 2 generations on0descendants
- K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc. · 2016 · 2 generations on0descendants
- K153153Reprocessed Electrophysiology CatheterInnovative Health, LLC · 2016 · cites it directly0descendants
- K130602Lasso Nav Duo Loop CatheterBiosense Webster, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220 | Biosense Webster, Inc. | 2000 | 2 |
| −2 | K031161 | Variable Lasso 2515 Circular Mapping Catheter | Biosense Webster, Inc. | 2003 | 2 |
| −1 | K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02 | Biosense Webster, Inc. | 2009 | — |
| 0 (this device) | K093376 | Lasso Nav Catheter | Biosense Webster, Inc. | 2010 | — |
| +1 | K113213 | Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From… | Biosense Webster, Inc. | 2011 | 1 |
| +2 | K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed… | CathRx, Ltd. | 2022 | — |
| +2 | K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology… | Sterilmed, Inc. | 2016 | — |
| +1 | K153153 | Reprocessed Electrophysiology Catheter | Innovative Health, LLC | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K002333 | Biosense Webster Lasso Deflectable Circular Mapping Catheter, Model D-1220Summary page 1…(per 21 CFR 870.1220; Product Code: DRE) Predicate Devices: LAsso® Deflectable Circular Mapping Catheter 510(k) K002333 LAsso® 2515 NAV Variable Circular Mapping Catheter 5 10(k) K08 1258… | 2000 |
| * | K081258 | Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Summary page 1…eter 510(k) K002333 LAsso® 2515 NAV Variable Circular Mapping Catheter 5 10(k) K08 1258 Manufacturer: Biosense Webster 3333 Diamond Canyon Road… | 2009 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 2.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K113213 (Biosense Webster, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K002333.
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. 2010, 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?
The LASSO® NAV Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or Stimulation only. This catheter is designed to obtain electrograms in the atrial regions of the heart.
The LASSO® NAV Catheter provides location information when used with compatible CARTo EP Navigation Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093376: Lasso Nav Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093376
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