The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Gamcath High Flow Catheter, Ref: Gdhk 13xx A.
| Device ID | K040301 |
| 510k Number | K040301 |
| Device Name: | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Contact | Thomas B Dowell |
| Correspondent | Thomas B Dowell GAMBRO RENAL PRODUCTS 10810 WEST COLLINS AVE. Lakewood, CO 80215 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-11-01 |
| Summary: | summary |