The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Gamcath High Flow Dolphin Ms-gdhc-1315 A; And Ms-gdhc-1315j A, Gamcath High Flow Dolphin Ms-gdhc-1320 A; And Ms-gdhc-132.
| Device ID | K100451 |
| 510k Number | K100451 |
| Device Name: | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 |
| Classification | Catheter, Hemodialysis, Non-implanted |
| Applicant | GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Contact | Kae Miller |
| Correspondent | Kae Miller GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401 |
| Product Code | MPB |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414110797 | K100451 | 000 |
| 37332414110674 | K100451 | 000 |
| 37332414110681 | K100451 | 000 |
| 37332414110698 | K100451 | 000 |
| 37332414110704 | K100451 | 000 |
| 37332414110711 | K100451 | 000 |
| 37332414110766 | K100451 | 000 |
| 37332414110773 | K100451 | 000 |
| 37332414110780 | K100451 | 000 |
| 37332414110667 | K100451 | 000 |