510(k) · Cleared
Recalled · 2007Chase Retrograde Cardioplegia Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chase Medical, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Apr 23, 1997 as substantially equivalent to K880103 (Research Medical, Inc., 1988) after a 170-day review. Its family tree reaches back 1 generation to 1988. It has been recalled 13 times.
- Decided
- Apr 23, 1997
- Review
- 170 days
- Class
- Class II
- Product code
- DWF
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880103 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK880103 Catheter, Cannula and Tubing, Vascular, Cardiopul.Research Medical, Inc. · 1988
- This deviceK964393 Chase Retrograde Cardioplegia CannulaChase Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul. | Research Medical, Inc. | 1988 | — |
| 0 (this device) | K964393 | Chase Retrograde Cardioplegia Cannula | Chase Medical, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K880103 | Catheter, Cannula and Tubing, Vascular, Cardiopul.Summary page 1…ification: Class Il V. Safety and Effectiveness Substantial Equivalence: The device is substantially equivalent to the Research Medical Retrograde Cardioplegia Cannula (K880103). Vi. Other Safety and Effectiveness Data Materials: All material are identical to the predicate device. Sterilization: Validat… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2007 | Not classified | Z-0892-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0893-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0894-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0897-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0901-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0903-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0895-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0896-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0898-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0899-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0900-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0902-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
| Apr 17, 2007 | Not classified | Z-0904-2007 | Other | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 6 other devices also cite its predicate K880103.
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 Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery.
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/K964393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964393: Chase Retrograde Cardioplegia Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964393
Report an extraction error
Are you the manufacturer?
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