510(k) · Cleared
Recalled · 2011Heartport Endocoronary Sinus Cathetr
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 Jan 22, 1997 as substantially equivalent to K961270 (Heartport, Inc., 1996) after a 90-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 22, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810360 (1981). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK810360 Baim TM Coronary Sinus Flow ThermalElectro-Catheter Corp. · 1981
- 1 generation backK961270 Heartport Endosinus CatheterHeartport, Inc. · 1996
- This deviceK964248 Heartport Endocoronary Sinus CathetrHeartport, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009
Most influential descendants
Showing 1 of 1 · See all- K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810360 | Baim TM Coronary Sinus Flow Thermal | Electro-Catheter Corp. | 1981 | — |
| −1 | K961270 | Heartport Endosinus Catheter | Heartport, Inc. | 1996 | — |
| 0 (this device) | K964248 | Heartport Endocoronary Sinus Cathetr | Heartport, Inc. | 1997 | — |
| +1 | K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate… | Medtronic Perfusion Systems | 2009 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K961270 | Heartport Endosinus CatheterSummary page 1…docoronary Sinus Catheter Sinus Catheter Cardiopulmonary bypass vascular catheter Name: Endosinus Catheter Manufacturer: Heartport, Inc. Status: Post-enactment 510(k) # K961270 Cleared: June 18, 1996 Heartport, Inc. CONFIDENTIAL 17 Endocoronary Sinus™ Catheter Appendices 510(k) Summary of… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090869 | Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula… | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2011 | Not classified | Z-2776-2011 | Employee error | Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters. |
| Dec 3, 2010 | Not classified | Z-0991-2011 | Device Design | Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 15.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K090869 (Medtronic Perfusion Systems, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K961270.
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?
The catheter is designed to provide occlusion of the coronary sinus, to deliver cardioplegic solution to the coronary sinus and to monitor the 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/K964248 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964248: Heartport Endocoronary Sinus Cathetr.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964248
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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