The following data is part of a premarket notification filed by Ash Access Technology, Inc. with the FDA for Ash Advance Hemodialysis Catheter And Procedure Kit, Models; 15fr X 24cm, 15fr X 28cm, 15fr X 32cm.
Device ID | K070572 |
510k Number | K070572 |
Device Name: | ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM |
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 | 2007-02-28 |
Decision Date | 2007-06-26 |
Summary: | summary |