The following data is part of a premarket notification filed by Applied Medical with the FDA for Expanding Vascular Sheath.
| Device ID | K070865 |
| 510k Number | K070865 |
| Device Name: | EXPANDING VASCULAR SHEATH |
| Classification | Introducer, Catheter |
| Applicant | APPLIED MEDICAL 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Cheryl Blake |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-29 |
| Decision Date | 2007-10-23 |
| Summary: | summary |