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 |