The following data is part of a premarket notification filed by Boston Scientific with the FDA for 6f Mach1/34356-xxx; 5f Mach1/35845-xxx; 7f Mach1/34357-xxx; 8f Mach1/34358-xxx.
| Device ID | K020028 |
| 510k Number | K020028 |
| Device Name: | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX |
| Classification | Catheter, Percutaneous |
| Applicant | BOSTON SCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Todd Kornmann |
| Correspondent | Todd Kornmann BOSTON SCIENTIFIC ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-04 |
| Decision Date | 2002-01-22 |
| Summary: | summary |