Flextra Steerable Introducer — Rhythm Xience, Inc. (Rxi) (510(k) K170373)
Flextra Steerable Introducer — Rhythm Xience, Inc. (Rxi) (510(k) K170373) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Flextra Steerable Introducer; Applicant: Rhythm Xience, Inc. (Rxi); Clearance track: 510(k).
| Device name | Flextra Steerable Introducer |
|---|---|
| Applicant | Rhythm Xience, Inc. (Rxi) |
| Clearance track | 510(k) |
| Submission number | K170373 |
| Decision | Substantially Equivalent |
| Decision date | 2017-02-27 |
| Date received | 2017-02-07 |
| Product code | DYB |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | MN, US |
| Source | openFDA device |
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