510(k) · Cleared
ClearedMircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Perfusion Systems · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Aug 27, 2009 as substantially equivalent to K860149 (Dlp, Inc., 1986) and 5 other predicates after a 149-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Aug 27, 2009
- Review
- 149 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K942299 (1995). 50 ancestors in all, the oldest K810360 (1981). No later device cites it as a predicate yet.
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 5 generations between
- 3 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 2 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 1 generation backK070311 Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular · 2007
- This deviceK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009
Show all 9 generations
- Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 3 generations backK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- 2 generations backK060400 Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate…Medtronic, Inc. · 2006
- 1 generation backK070311 Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Medtronic Vascular · 2007
- This deviceK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −8 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −7 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −6 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −5 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −4 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −3 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| −2 | K060400 | Cardioblate Surgical Ablation Generator, Model 68000; Cardioblate BP2 Surgical… | Medtronic, Inc. | 2006 | — |
| −1 | K070311 | Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261 | Medtronic Vascular | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1981 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 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? (8)
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 |
|---|---|---|---|
| * | K860149 | Venous Perfusion Cannula W/Cuff Cat. NO. 94015Summary page 1…or tubing Regulation Number: 21 CFR 870.4210 Product Code: DWF Classification: Class II Predicate Devices • Medtronic DLP Venous Perfusion Cannula with Cuff (K860149) • Medtronic DLP Silicone RCSP Cannula with Auto-Inflate Cuff (K901074) * RMI (Edwards Lifesciences) Steerable Retrograde Car… | 1986 |
| * | K901074 | Code #94315 Retrograde Coronary Sinus Perf CannulaSummary page 1…sification: Class II Predicate Devices • Medtronic DLP Venous Perfusion Cannula with Cuff (K860149) • Medtronic DLP Silicone RCSP Cannula with Auto-Inflate Cuff (K901074) * RMI (Edwards Lifesciences) Steerable Retrograde Cardioplegia Cannula (KOO 1565) • Heartport (Edwards Lifesciences) Direct… | 1990 |
| * | K001565 | Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models… | 2000 |
| * | K994243 | Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip…Summary page 1…s Lifesciences) Steerable Retrograde Cardioplegia Cannula (KOO 1565) • Heartport (Edwards Lifesciences) Direct Arterial Cannula (previously known as StraightShot) (K994243) * Heartport (Edwards Lifesciences) Endocoronary Sinus Catheter (K964248) · Medtronic Cardioblate Gemini Device (K070311) De… | 2000 |
| * | K964248 | Heartport Endocoronary Sinus CathetrSummary page 1…artport (Edwards Lifesciences) Direct Arterial Cannula (previously known as StraightShot) (K994243) * Heartport (Edwards Lifesciences) Endocoronary Sinus Catheter (K964248) · Medtronic Cardioblate Gemini Device (K070311) Device Description MiRCSP Cannulae are single-use, sterile, nonpyrogenic devi… | 1997 |
| * | K070311 | Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261Summary page 1…nula (previously known as StraightShot) (K994243) * Heartport (Edwards Lifesciences) Endocoronary Sinus Catheter (K964248) · Medtronic Cardioblate Gemini Device (K070311) Device Description MiRCSP Cannulae are single-use, sterile, nonpyrogenic devices designed to deliver cardioplegia through the c… | 2007 |
| * | — | Medtronic RCSP Model 94113 Named without a submission number | |
| * | — | Medtronic RCSP Model 94533 Named without a submission number |
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 14 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 50 ancestors have a recall of any class.
- 2 other devices also cite its predicate K860149.
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. 2009, 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 MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090869
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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