The following data is part of a premarket notification filed by Deltec, Inc. with the FDA for Truflow Long-term And Short-term Dual-lumen Dialysis Catheters.
| Device ID | K022221 |
| 510k Number | K022221 |
| Device Name: | TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS |
| Classification | Catheter, Hemodialysis, Non-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 | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-09 |
| Decision Date | 2003-01-30 |
| Summary: | summary |