The following data is part of a premarket notification filed by Guided Delivery Systems with the FDA for Gds-dcs.
| Device ID | K091367 |
| 510k Number | K091367 |
| Device Name: | GDS-DCS |
| Classification | Introducer, Catheter |
| Applicant | GUIDED DELIVERY SYSTEMS 2355 CALLE DE LUNA Santa Clara, CA 95054 |
| Contact | Bonnie Mcinerney |
| Correspondent | Bonnie Mcinerney GUIDED DELIVERY SYSTEMS 2355 CALLE DE LUNA Santa Clara, CA 95054 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-11-05 |
| Summary: | summary |