The following data is part of a premarket notification filed by Std Mfg., Inc. with the FDA for Vascular Closure Device.
| Device ID | K003169 |
| 510k Number | K003169 |
| Device Name: | VASCULAR CLOSURE DEVICE |
| Classification | Staple, Implantable |
| Applicant | STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Contact | Stephen M Palumbo |
| Correspondent | Stephen M Palumbo STD MFG., INC. 1063 TURNPIKE ST. P.O. BOX 420 Stoughton, MA 02072 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-12-08 |