The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Arrow(r) Nextstep Tm Antegrade Chronic Hemodialysis Catheter.
| Device ID | K102238 |
| 510k Number | K102238 |
| Device Name: | ARROW(R) NEXTSTEP TM 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 (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2011-02-01 |
| Summary: | summary |