The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Intravascular Introducer System.
| Device ID | K063658 |
| 510k Number | K063658 |
| Device Name: | INTRAVASCULAR INTRODUCER SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Cheryl Blake |
| Correspondent | Cheryl Blake APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-08 |
| Decision Date | 2007-09-12 |
| Summary: | summary |