The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Vascular Plug Ii, Models Avp2-003, Avp2-018, Avp2-020, Avp2-022.
| Device ID | K071699 |
| 510k Number | K071699 |
| Device Name: | AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 |
| 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 | 2007-06-21 |
| Decision Date | 2007-08-15 |
| Summary: | summary |