The following data is part of a premarket notification filed by Aga Medical Corp. with the FDA for Amplatzer Reliant Catheter Delivery System.
| Device ID | K070238 |
| 510k Number | K070238 |
| Device Name: | AMPLATZER RELIANT CATHETER DELIVERY SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | AGA MEDICAL CORP. 682 MENDELSSOHN AVE. Plymouth, MN 55427 |
| Contact | David D Cox |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-02-28 |
| Summary: | summary |