510(k) · Cleared
ClearedHeartport Endosinus Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jun 18, 1996 as substantially equivalent to K897137 (Research Medical, Inc., 1990) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1981. 3 later devices descend from it.
- Decided
- Jun 18, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810360 (1981). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK810360 Baim TM Coronary Sinus Flow ThermalElectro-Catheter Corp. · 1981
- This deviceK961270 Heartport Endosinus CatheterHeartport, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK964248 Heartport Endocoronary Sinus CathetrHeartport, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 0 of its ownK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009
- Descendant · cites it directly · 0 of its ownK962858 Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem…Heartport, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K964248Heartport Endocoronary Sinus CathetrHeartport, Inc. · 1997 · cites it directly1descendant
- K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems · 2009 · 2 generations on0descendants
- K962858Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number…Heartport, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810360 | Baim TM Coronary Sinus Flow Thermal | Electro-Catheter Corp. | 1981 | — |
| 0 (this device) | K961270 | Heartport Endosinus Catheter | Heartport, Inc. | 1996 | — |
| +1 | K964248 | Heartport Endocoronary Sinus Cathetr | Heartport, Inc. | 1997 | 2 |
| +2 | K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate… | Medtronic Perfusion Systems | 2009 | — |
| +1 | K962858 | Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog… | Heartport, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2009 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · 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 |
|---|---|---|---|
| * | K897137 | Rmi Aortic Root/Coronary Sinus Pressure MonitoringSummary page 1…scular catheter Equivalent Devices: Name: Coronary Sinus Perfusion & Pressure Monitoring Cannula Manufacturer: Research Medical, Inc. Status: Post-enactment S10(k) # K897137 Name: Baim Coronary Sinus Flow Catheter Manufacturer: Electro-Catheter Corporation Status: Post-enactment 510(k) # K810360 H… | 1990 |
| * | K810360 | Baim TM Coronary Sinus Flow ThermalSummary page 1…al, Inc. Status: Post-enactment S10(k) # K897137 Name: Baim Coronary Sinus Flow Catheter Manufacturer: Electro-Catheter Corporation Status: Post-enactment 510(k) # K810360 Heartport, Inc. CONFIDENTIAL 15 Endosinus Catheter Appendices 510(k) Summary of Safety and Effectiveness (conti… | 1981 |
What descends from it? (3)
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K964248 (Heartport, Inc., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961270 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961270: Heartport Endosinus Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961270
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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