FDA Product Code
FDA Product Code OBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019-09-13 | Traditional | PDF ↗ |
Product code OBI · Class II · Cardiovascular. Data: openFDA.