The following data is part of a premarket notification filed by Boston Scientific with the FDA for Convoy Advanced Delivery Sheath.
| Device ID | K022067 |
| 510k Number | K022067 |
| Device Name: | CONVOY ADVANCED DELIVERY SHEATH |
| Classification | Fab, Rhodamine, Antigen, Antiserum, Control |
| Applicant | BOSTON SCIENTIFIC 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Andrea L Ruth |
| Correspondent | Andrea L Ruth BOSTON SCIENTIFIC 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | DBY |
| CFR Regulation Number | 866.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-25 |
| Decision Date | 2002-09-11 |
| Summary: | summary |