The following data is part of a premarket notification filed by Maxxim Medical with the FDA for Vessel Dilator.
| Device ID | K963388 |
| 510k Number | K963388 |
| Device Name: | VESSEL DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Contact | Richard A Hamer |
| Correspondent | Richard A Hamer MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 Fort Worth, TX 76102 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-28 |
| Decision Date | 1997-03-11 |
| Summary: | summary |