The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Proguide Chronic Dialysis Catheter.
| Device ID | K042016 |
| 510k Number | K042016 |
| Device Name: | DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | DATASCOPE CORP. 1300 MACARTHUR BLVD MAHWAH, NJ 07430 |
| Contact | PATRICE NAPODA |
| Correspondent | PATRICE NAPODA DATASCOPE CORP. 1300 MACARTHUR BLVD MAHWAH, NJ 07430 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-27 |
| Decision Date | 2004-09-23 |