510(k) · Cleared
Recalled · Class II · 2026Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dlp, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Mar 26, 1996 after a 218-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 8 times.
- Decided
- Mar 26, 1996
- Review
- 218 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 8
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK953945 Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded…Dlp, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK253203 Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953945 | Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff &… | Dlp, Inc. | 1996 | — |
| +1 | K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | — | DLP marketed RCSP cannula Named without a submission number | |
| * | — | Research Medical marketed RCSP cannula Named without a submission number | |
| * | — | Sarns 3M marketed RCSP cannula Named without a submission number |
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 |
|---|---|---|---|
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class II | Z-2217-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2214-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2216-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2220-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2219-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2222-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2218-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
| Apr 21, 2026 | Class II | Z-2221-2026 | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K253203 (Medtronic, Inc., 2026) has gone furthest, with 0 descendants 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?
The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.
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/K953945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953945: Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953945
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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