The following data is part of a premarket notification filed by Cutting Edge Technologies, Inc. with the FDA for Seragard Vascular Access Device.
| Device ID | K963595 |
| 510k Number | K963595 |
| Device Name: | SERAGARD VASCULAR ACCESS DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CUTTING EDGE TECHNOLOGIES, INC. 889 SOUTH MATLACK ST. West Chester, PA 19382 |
| Contact | Walter L Yates |
| Correspondent | Walter L Yates CUTTING EDGE TECHNOLOGIES, INC. 889 SOUTH MATLACK ST. West Chester, PA 19382 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-09 |
| Decision Date | 1997-01-06 |