The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Vascular Plug Ii Models: Avp2-004, Avp2-006, Avp2-008, Avp2-010, Avp2-012, Avp2-014, Avp2-016.
| Device ID | K071125 |
| 510k Number | K071125 |
| Device Name: | AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Jodi L Raus |
| Correspondent | Jodi L Raus AGA MEDICAL CORP. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-23 |
| Decision Date | 2007-06-18 |
| Summary: | summary |