# K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Perfusion Systems
- Decided: Aug 27, 2009 after 149 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K942299 (1995). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860149: Venous Perfusion Cannula W/Cuff Cat. NO. 94015, Dlp, Inc. (1986) Summary page 1.
- K901074: Code #94315 Retrograde Coronary Sinus Perf Cannula, Dlp, Inc. (1990) Summary page 1.
- K001565: Steerable Retrograde Cardioplegia Cannula with and Without Duraflo Treatment, Models SRCO14MIB, DIISRCO14MIB, Edwards Lifesciences, LLC (2000)
- K994243: Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip, Heartport, Inc. (2000) Summary page 1.
- K964248: Heartport Endocoronary Sinus Cathetr, Heartport, Inc. (1997) Summary page 1.
- K070311: Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261, Medtronic Vascular (2007) Summary page 1.
- (no number) Medtronic RCSP Model 94113: named in the summary without a submission number
- (no number) Medtronic RCSP Model 94533: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K090869
Methodology: https://510kreport.com/methodology