510(k) K964393 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CHASE RETROGRADE CARDIOPLEGIA CANNULA
| Applicant | Chase Medical, Inc., Richardson TX, US |
| Decision | Substantially Equivalent, Apr 23, 1997 |
| Received | Nov 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, guidewire stylet, sterile, REF CODE: RSG-M014S. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC 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. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC 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. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, handle stylet, sterile, REF CODE: RSH-L014S. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, handle stylet, sterile, REF CODE: RSH-M014S. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC 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. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC 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. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, handle stylet, sterile, REF CODE: RSH-T014S. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC 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-T Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm, rigid insertion stylet, sterile, REF CODE: RSR-L014S. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC 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. Terminated |
DWF | None listed |
| Jun 6, 2007 | Surge Medical Solutions, LLC Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.