Scion Cardiovascular, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Scion Cardiovascular, Inc. makes
Scion Cardiovascular, Inc. manufactures the SCIPRO™ Flexible Stone Dislodger and Retrieval Set, a device designed for the removal of calcified renal stones during percutaneous nephrolithotomy procedures.
The SCIPRO™ Flexible Stone Dislodger and Retrieval Set is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Clo-Surplus P.A.D. Ref K092552
Regimes: 510(k) Registry: 510(k)M-Bolus Embolic Microspheres Ref K052509
Regimes: 510(k) Registry: 510(k)Clo-Surplusp.a.d. Ref K032986
Regimes: 510(k) Registry: 510(k)Clo-Surplus P.A.D. Ref K112961
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Scion Cardiovascular, Inc., the earliest on 2003-05-23 and the most recent on 2003-06-30. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 30 Jun 2003 Z-0557-04 Unclassified (pre-2012) Terminated The firm received field complaints that it was difficult to open the stone retrieval basket during use.
- 23 May 2003 Z-0554-04 Unclassified (pre-2012) Terminated Possible difficulty for the user in opening the stone retrieval basket.
Frequently asked questions
How many devices does Scion Cardiovascular, Inc. have in the registry?
The registry currently lists 5 devices for Scion Cardiovascular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scion Cardiovascular, Inc.'s devices?
Among its 5 most recently registered devices, Scion Cardiovascular, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Scion Cardiovascular, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Scion Cardiovascular, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Scion Cardiovascular, Inc.?
FDA recall records list 2 recalls initiated by Scion Cardiovascular, Inc., the most recent initiated on 30 Jun 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Scion Cardiovascular, Inc. in the registry?
The most recently registered devices listed for Scion Cardiovascular, Inc. include CLO-SURPLUS P.A.D., M-BOLUS EMBOLIC MICROSPHERES, CLO-SURPLUSP.A.D. and SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET.