The following data is part of a premarket notification filed by Invatec Innovative Technologies with the FDA for Admiral Xtreme Pta Catheter.
Device ID | K062809 |
510k Number | K062809 |
Device Name: | ADMIRAL XTREME PTA CATHETER |
Classification | Catheter, Percutaneous |
Applicant | INVATEC INNOVATIVE TECHNOLOGIES 9600 54TH AVENUE NORTH Plymouth, MN 55442 |
Contact | David Worrell |
Correspondent | David Worrell INVATEC INNOVATIVE TECHNOLOGIES 9600 54TH AVENUE NORTH Plymouth, MN 55442 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-19 |
Decision Date | 2006-10-18 |
Summary: | summary |