The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Ct Syringe For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), Ct Syringe Dual Pack For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), Single Fascia And Ram Tip, Dual Fascia And Ram Tip.
| Device ID | K170431 |
| 510k Number | K170431 |
| Device Name: | CT Syringe For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack For Stellant Injectors (with & Without Spikes, Prime Tubes, & Fill Tubes), Single Fascia And Ram Tip, Dual Fascia And Ram Tip |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Coeur, Inc. 100 Physicians Way Lebanon, TN 37090 |
| Contact | Priscilla Clinner |
| Correspondent | Priscilla Clinner Coeur, Inc. 100 Physicians Way Lebanon, TN 37090 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-13 |
| Decision Date | 2017-08-18 |
| Summary: | summary |