The following data is part of a premarket notification filed by Centerpoint Systems with the FDA for Delivery Catheter Sspc1, Delivery Catheter Sspc2, Delivery Catheter Sspc3, Delivery Catheter Sspc4.
| Device ID | K190475 |
| 510k Number | K190475 |
| Device Name: | Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 |
| Classification | Catheter, Percutaneous |
| Applicant | CenterPoint Systems 3338 Parkway Blvd West Valley City, UT 84119 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber CenterPoint Systems 3338 Parkway Blvd West Valley City, UT 84119 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810024671847 | K190475 | 000 |
| 00810024671830 | K190475 | 000 |
| 00810024671823 | K190475 | 000 |
| 00810024671816 | K190475 | 000 |