The following data is part of a premarket notification filed by Straub Medical Ag with the FDA for Rotarex S Catheter Set – 6f X 110 Cm, Rotarex S Catheter Set – 6f X 135 Cm, Rotarex S Catheter Set – 8f X 85 Cm, Rotarex S Catheter Set – 8f X 110 Cm, Drive System, Replacement Control Unit (with Cord), Replacement Motor (with Cord), Replacement Foot.
| Device ID | K172315 |
| 510k Number | K172315 |
| Device Name: | Rotarex S Catheter Set – 6F X 110 Cm, Rotarex S Catheter Set – 6F X 135 Cm, Rotarex S Catheter Set – 8F X 85 Cm, Rotarex S Catheter Set – 8F X 110 Cm, Drive System, Replacement Control Unit (with Cord), Replacement Motor (with Cord), Replacement Foot |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | Straub Medical AG Straubstrasse 12 Wangs, CH Ch 7323 |
| Contact | Amy Ehlenfeldt |
| Correspondent | Barbara Atzenhoefer NAMSA 400 Hwy 169 South Suite 500 Minneapolis, MN 55426 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-01 |
| Decision Date | 2018-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640142811190 | K172315 | 000 |
| 07640142810292 | K172315 | 000 |
| 07640142810353 | K172315 | 000 |
| 07640142810384 | K172315 | 000 |
| 07640142810193 | K172315 | 000 |
| 07640142810247 | K172315 | 000 |
| 07640142810254 | K172315 | 000 |
| 07640142810261 | K172315 | 000 |
| 07640142810575 | K172315 | 000 |
| 07640142810582 | K172315 | 000 |
| 07640142810599 | K172315 | 000 |
| 07640142810605 | K172315 | 000 |
| 07640142810612 | K172315 | 000 |
| 07640142810872 | K172315 | 000 |
| 07640142810889 | K172315 | 000 |
| 07640142810902 | K172315 | 000 |
| 07640142810919 | K172315 | 000 |
| 07640142810278 | K172315 | 000 |