The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Noodlewire Guidewire.
| Device ID | K053187 |
| 510k Number | K053187 |
| Device Name: | AMPLATZER NOODLEWIRE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Golden Valley, MN 55427 |
| Contact | Patricia A Laforet |
| Correspondent | Patricia A Laforet AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Golden Valley, MN 55427 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-15 |
| Decision Date | 2006-04-27 |
| Summary: | summary |