Scion Cardio-Vascular, Inc.
Miami, FL, US
Scion Cardio-Vascular, Inc. appears in FDA device records in Miami, FL. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Scion Cardio-Vascular, Inc. between 2004 and 2011. The busiest year on record is 2004, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112961 | CLO-SURPLUS P.A.D. | QSY | Substantially Equivalent | |
| K092552 | CLO-SURPLUS P.A.D. | QSY | Substantially Equivalent | |
| K052509 | M-BOLUS EMBOLIC MICROSPHERES | HCG | Substantially Equivalent | |
| K032986 | CLO-SURPLUSP.A.D. | QSY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0557-04 | 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 gatroenterological procedures. The device has the manufacturer listed on the label which is Scion Cardio-Vascular, Inc., 14256 SW 119 Avenue, Miami, FL 33186. | The firm received field complaints that it was difficult to open the stone retrieval basket during use. | Terminated | ||
| Z-0554-04 | SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST | Possible difficulty for the user in opening the stone retrieval basket. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain