510(k) · Cleared
ClearedMarinr Series EP Diagnostic Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cardiorhythm · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jun 6, 1994 after a 420-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 of the 131 devices in its family, counting itself, have a Class I recall. 130 later devices descend from it.
- Decided
- Jun 6, 1994
- Review
- 420 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
130 later devices descend from it, 7 citing it directly. 8 of the 131 devices in this family, counting this one, have a Class I recall.
- This deviceK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- Descendant · cites it directly · 119 of its ownK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- Descendant · cites it directly · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- Descendant · 2 generations on · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- Descendant · 2 generations on · 37 of its ownK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- Descendant · 2 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 130 · See all- K974683Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999 · cites it directly119descendants
- K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · cites it directly80descendants
- K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · 2 generations on37descendants
- K012749Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002 · 2 generations on37descendants
- K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| +1 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| +1 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| +2 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| +2 | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| +2 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 2 |
| 2005 | 7 | 0 |
| 2006 | 9 | 1 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 1 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 1 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 1 |
| 2022 | 2 | 1 |
| 2023 | 6 | 0 |
| 2024 | 7 | 1 |
| 2025 | 7 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
8 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (130)
See all 1307 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974683 | Naviport Deflectable Tip Guiding Catheter | 1999 | 119 |
| K013517 | 10600 Deflectable Catheter System, Model 10600 | 2002 | 80 |
| K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | 2003 | 29 |
| K012708 | Electrophysiology Catheter | 2002 | 5 |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac… | 2019 | 1 |
| K181897 | Reprocessed Marinr Diagnostic EP Catheter | 2018 | 0 |
| K030279 | Reprocessed Electrophysiology Catheter | 2003 | 0 |
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 5 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- Of its descendants, K974683 (Cardima, Inc., 1999) has gone furthest, with 119 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K931794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931794: Marinr Series EP Diagnostic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931794
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026