TIR/TIJ AND POLYROX — Biotronik, Inc. (510(k) K972500)
TIR/TIJ AND POLYROX — Biotronik, Inc. (510(k) K972500) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: TIR/TIJ AND POLYROX; Applicant: Biotronik, Inc.; Clearance track: 510(k).
| Device name | TIR/TIJ AND POLYROX |
|---|---|
| Applicant | Biotronik, Inc. |
| Clearance track | 510(k) |
| Submission number | K972500 |
| Decision | Substantially Equivalent - Subject to Tracking & PMS |
| Decision date | 1998-03-04 |
| Date received | 1997-07-03 |
| Product code | DTB |
| Device class | 3 |
| Medical specialty | Cardiovascular |
| Applicant location | OR, US |
| Source | openFDA device |
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