Surge Medical Solutions, LLC
Grand Rapids, MI
Surge Medical Solutions, LLC appears in FDA device records in Grand Rapids, MI. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 13 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 13
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0904-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0903-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm and rigid stylet, 12.5'(31.8cm), sterile, REF CODE: RSR-M014S-L. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0902-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0901-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, rigid insertion stylet, sterile, REF CODE: RSR-L014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0900-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm self-inflating textured balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-T014S-L. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0899-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, handle stylet, sterile, REF CODE: RSH-T014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0898-2007 | Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0897-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0896-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0895-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, handle stylet, sterile, REF CODE: RSH-L014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0894-2007 | Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon, 15Fr (5.0mm), guidewire stylet, 12.5'(31.8cm), sterile, REF CODE: RSG-T014S-L. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0893-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, 12.5' (31.8cm), sterile, REF CODE: RSG-M014S-L. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated | ||
| Z-0892-2007 | Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S. | The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain