510(k) · Cleared
ClearedDLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, DLP Retrograde Coronary Sinus Perfusio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Oct 31, 2013 as substantially equivalent to K030696 (Medtronic Perfusion Systems, 2003) after a 37-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Oct 31, 2013
- Review
- 37 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860149 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK860149 Venous Perfusion Cannula W/Cuff Cat. NO. 94015Dlp, Inc. · 1986 · Recalled
- 1 generation backK030696 Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line…Medtronic Perfusion Systems · 2003
- This deviceK132995 DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure…Medtronic, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860149 | Venous Perfusion Cannula W/Cuff Cat. NO. 94015 | Dlp, Inc. | 1986 | 9 |
| −1 | K030696 | Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French… | Medtronic Perfusion Systems | 2003 | — |
| 0 (this device) | K132995 | DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring… | Medtronic, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 |
|---|---|---|---|
| * | K030696 | Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and…Summary page 1…d Tubing, Vascular, Cardiopulmonary Bypass Regulation Number: 21 CFR 870.42 10 Product Code: DWF Product Classification: Class 11 Predicate Devices K030696 Retrograde Coronary Sinus Perfusion Cannula with no Pressure Monitoring Line === Pag… | 2003 |
| † | K120988 | DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single… | 2012 |
| † | K123762 | DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate Cuff | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 3 companies; a new generation was cleared every 17.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K030696.
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. 2013, this device’s year, is highlighted.
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 cannula is intended for use during cardiopulmonary bypass surgery for the delivery of cardioplegia retrogradely through the coronary sinus up to six hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132995: DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, DLP Retrograde Coronary Sinus Perfusio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132995
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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