The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Pathfinder Ii Angiographic Catheter.
| Device ID | K990173 |
| 510k Number | K990173 |
| Device Name: | PATHFINDER II ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Contact | Eddie Monroe |
| Correspondent | Eddie Monroe MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-12-21 |
| Summary: | summary |