The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Introducer With Distal Radiopaque Marker Band, Model Or-4926xx.
| Device ID | K002847 |
| 510k Number | K002847 |
| Device Name: | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX |
| Classification | Introducer, Catheter |
| Applicant | MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Contact | Gail Doherty |
| Correspondent | Gail Doherty MAXXIM MEDICAL 1445 FLAT CREEK RD. Athens, TX 75751 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2001-05-31 |