The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Sizing Balloon.
| Device ID | K993248 |
| 510k Number | K993248 |
| Device Name: | AMPLATZER SIZING BALLOON |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Golden Valley, MN 55427 |
| Contact | Jodi L Locher |
| Correspondent | Jodi L Locher AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Golden Valley, MN 55427 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-28 |
| Decision Date | 2000-07-12 |
| Summary: | summary |