Guider Catheter Introducer — Rhythm Xience, Inc. (Rxi) (510(k) K171081)
Guider Catheter Introducer — Rhythm Xience, Inc. (Rxi) (510(k) K171081) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Guider Catheter Introducer; Applicant: Rhythm Xience, Inc. (Rxi); Clearance track: 510(k).
| Device name | Guider Catheter Introducer |
|---|---|
| Applicant | Rhythm Xience, Inc. (Rxi) |
| Clearance track | 510(k) |
| Submission number | K171081 |
| Decision | Substantially Equivalent |
| Decision date | 2017-05-09 |
| Date received | 2017-04-11 |
| Product code | DYB |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | MN, US |
| Source | openFDA device |
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$1999/mo
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