Radifocus Optitorque Angiographic Catheter
by Ashitaka Factory of Terumo Corp. Japan(FDA 510(k) applicant) 510(k)
510(k) K150232 Product code DQO
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150232 | Date19 Oct 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ashitaka Factory of Terumo Corporation
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K150232