The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Strada Carotid Guiding Sheath.
| Device ID | K070166 |
| 510k Number | K070166 |
| Device Name: | STRADA CAROTID GUIDING SHEATH |
| Classification | Introducer, Catheter |
| Applicant | ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 Maple Grove, MN 55311 |
| Contact | Jeff Sturm |
| Correspondent | Jeff Sturm ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 Maple Grove, MN 55311 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-18 |
| Decision Date | 2007-04-06 |
| Summary: | summary |