510(k) K122937 ยท DQO Catheter, Intravascular, Diagnostic
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Dec 14, 2012 |
| Received | Sep 24, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2016 | Cook Inc. Shuttle Select Slip-Cath
Catheter, Intravascular, Diagnostic
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques Terminated |
DQO | None listed |
| Aug 22, 2016 | Cook Inc. Slip-Cath Beacon Tip Catheter
Catheter, Intravascular, Diagnostic
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Terminated |
DQO | None listed |
| Feb 24, 2016 | Cook Inc. Shuttle Select Slip-Cath Catheter. Angiographic catheter.
For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. T Terminated |
DQO | None listed |
| Aug 5, 2015 | Cook Inc. Slip-Cath Beacon Tip Catheter. Angiographic catheter.
For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.