The following data is part of a premarket notification filed by Centerpoint Systems Llc with the FDA for Guiding Catheter.
| Device ID | K210009 |
| 510k Number | K210009 |
| Device Name: | Guiding Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | CenterPoint Systems LLC 3338 Parkway Blvd West Valley City, UT 84119 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber CenterPoint Systems LLC 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 | 2021-01-04 |
| Decision Date | 2021-11-24 |