The following data is part of a premarket notification filed by Deltec, Inc. with the FDA for Truflow Dual-lumen Polyurethane Long-term Straight Dialysis Catheter (12.5 Fr X 24 Cm) With Tray, Truflow Dual-lumen Poy.
| Device ID | K030983 |
| 510k Number | K030983 |
| Device Name: | TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-28 |
| Decision Date | 2003-04-25 |
| Summary: | summary |