The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Nextstep Antegrade Chronic Hemodialysis Catheter.
| Device ID | K111900 |
| 510k Number | K111900 |
| Device Name: | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading, PA 19605 |
| Contact | Suzanne Schorle |
| Correspondent | Suzanne Schorle Teleflex Medical, Inc. 2400 BERNVILLE ROAD 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 | 2011-07-05 |
| Decision Date | 2011-08-17 |
| Summary: | summary |