The following data is part of a premarket notification filed by Arrow International, Inc. with the FDA for Nextstep Retrograde.
| Device ID | K130192 |
| 510k Number | K130192 |
| Device Name: | NEXTSTEP RETROGRADE |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Gwen Taschner |
| Correspondent | Gwen Taschner ARROW INTERNATIONAL, INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30801902096518 | K130192 | 000 |
| 30801902096464 | K130192 | 000 |
| 30801902082689 | K130192 | 000 |
| 30801902082672 | K130192 | 000 |