The following data is part of a premarket notification filed by Ash Access Technology, Inc. with the FDA for Centros Chronic Hemodialysis Catheter Set.
| Device ID | K092597 |
| 510k Number | K092597 |
| Device Name: | CENTROS CHRONIC HEMODIALYSIS CATHETER SET |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | ASH ACCESS TECHNOLOGY, INC. 3601 SAGAMORE PKWY N SUITE B Lafayette, IN 47904 |
| Contact | Roland Winger |
| Correspondent | Roland Winger ASH ACCESS TECHNOLOGY, INC. 3601 SAGAMORE PKWY N SUITE B Lafayette, IN 47904 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2009-11-12 |
| Summary: | summary |