510(k) · Cleared
ClearedSpherical Tip Coronary Ostial Cannula, Model 30011
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Jan 29, 2004 as substantially equivalent to K821149 (Dlp, Inc., 1982) after a 30-day review. Its family tree reaches back 1 generation to 1982. 4 later devices descend from it.
- Decided
- Jan 29, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K821149 (1982). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK821149 Submission Coronary CannulaDlp, Inc. · 1982
- This deviceK034058 Spherical Tip Coronary Ostial Cannula, Model 30011Medtronic Vascular · 2004
- Descendant · cites it directly · 3 of its ownK131269 DLP Coronary Ostial Perfusion CannulaeMedtronic, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK141951 DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK231206 DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK230960 DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K131269DLP Coronary Ostial Perfusion CannulaeMedtronic, Inc. · 2013 · cites it directly3descendants
- K141951DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2014 · 2 generations on2descendants
- K231206DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023 · 3 generations on0descendants
- K230960DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821149 | Submission Coronary Cannula | Dlp, Inc. | 1982 | — |
| 0 (this device) | K034058 | Spherical Tip Coronary Ostial Cannula, Model 30011 | Medtronic Vascular | 2004 | — |
| +1 | K131269 | DLP Coronary Ostial Perfusion Cannulae | Medtronic, Inc. | 2013 | 1 |
| +2 | K141951 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2014 | — |
| +3 | K231206 | DLP Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023 | — |
| +3 | K230960 | DLP™ Silicone Coronary Artery Ostial Cannulae | Medtronic, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K821149 | Submission Coronary CannulaSummary page 1…nary bypass vascular catheter, cannula or tubing Classification: Class II Predicate Devices: Coronary Cannula - K821 149 Models 30010,30012,30014 - French 10, 12 and 14 French Device Description: The Spherical Coronar… | 1982 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131269 | DLP Coronary Ostial Perfusion Cannulae | 2013 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K131269 (Medtronic, Inc., 2013) has gone furthest, with 3 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 Spherical Tip Coronary Ostial Cannula is intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less, for delivery of cardioplegia solutions directly to the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034058: Spherical Tip Coronary Ostial Cannula, Model 30011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034058
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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