The following data is part of a premarket notification filed by Rhythm Xience, Inc. (rxi) with the FDA for Flextra Steerable Introducer.
| Device ID | K170373 |
| 510k Number | K170373 |
| Device Name: | Flextra Steerable Introducer |
| Classification | Introducer, Catheter |
| Applicant | Rhythm Xience, Inc. (RXI) 10025 Valley View Road, Suite 130 Eden Prairie, MN 55344 |
| Contact | James Hassett |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-02-07 |
| Decision Date | 2017-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852392007019 | K170373 | 000 |
| 00852392007002 | K170373 | 000 |