The following data is part of a premarket notification filed by Guided Delivery Systems with the FDA for Gds-dc12.
| Device ID | K100135 |
| 510k Number | K100135 |
| Device Name: | GDS-DC12 |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDED DELIVERY SYSTEMS 2355 CALLE DE LUNA Santa Clara, CA 95054 |
| Contact | Bonnie L Mcinerney |
| Correspondent | Bonnie L Mcinerney GUIDED DELIVERY SYSTEMS 2355 CALLE DE LUNA Santa Clara, CA 95054 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-19 |
| Decision Date | 2010-04-16 |
| Summary: | summary |