The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Vascular Plug.
| Device ID | K031810 |
| 510k Number | K031810 |
| Device Name: | AMPLATZER VASCULAR PLUG |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Golden Valley, MN 55427 |
| Contact | Patrice M Stromberg |
| Correspondent | Patrice M Stromberg AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Golden Valley, MN 55427 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-09-09 |
| Summary: | summary |