Company ยท US
Scion Cardio-Vascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2011. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 2011 | K112961 | CLO-SURPLUS P.A.D. Scion Cardio-Vascular, Inc. | QSY |
| Sep 4, 2009 | K092552 | CLO-SURPLUS P.A.D. Scion Cardio-Vascular, Inc. | QSY |
| Dec 11, 2006 | K052509 | M-BOLUS EMBOLIC MICROSPHERES Scion Cardio-Vascular, Inc. | HCG |
| Mar 1, 2004 | K032986 | CLO-SURPLUSP.A.D. Scion Cardio-Vascular, Inc. | QSY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2004 | Scion Cardio-Vascular, Inc. The device is SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroent Terminated |
FGO | K001563 |
| Feb 27, 2004 | Scion Cardio-Vascular, Inc. SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST Terminated |
FGO | K001563 |