The following data is part of a premarket notification filed by Pendracare International, B.v. with the FDA for Convey Guiding Catheter.
| Device ID | K120585 |
| 510k Number | K120585 |
| Device Name: | CONVEY GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | PENDRACARE INTERNATIONAL, B.V. 7205 LAKETREE DR Raleigh, NC 27615 |
| Contact | Tom Nolan |
| Correspondent | Tom Nolan PENDRACARE INTERNATIONAL, B.V. 7205 LAKETREE DR Raleigh, NC 27615 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-08-08 |
| Summary: | summary |