The following data is part of a premarket notification filed by Micrus Design Technology, Inc. with the FDA for Peripheral Guiding Sheath.
| Device ID | K070816 |
| 510k Number | K070816 |
| Device Name: | PERIPHERAL GUIDING SHEATH |
| Classification | Introducer, Catheter |
| Applicant | MICRUS DESIGN TECHNOLOGY, INC. 9344 N.W. 13TH ST. Miami, FL 33172 |
| Contact | Marianne Grunwaldt, Ms, Cqe |
| Correspondent | Marianne Grunwaldt, Ms, Cqe MICRUS DESIGN TECHNOLOGY, INC. 9344 N.W. 13TH ST. Miami, FL 33172 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-09-19 |
| Summary: | summary |