The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Delivery Sheath, Model Adelante Breezeway.
| Device ID | K101497 |
| 510k Number | K101497 |
| Device Name: | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY |
| Classification | Introducer, Catheter |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-10-20 |
| Summary: | summary |