The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Vascular Plug 4.
| Device ID | K113658 |
| 510k Number | K113658 |
| Device Name: | AMPLATZER VASCULAR PLUG 4 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Sherry Kollmann |
| Correspondent | Sherry Kollmann AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-12 |
| Decision Date | 2012-06-12 |
| Summary: | summary |