The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angiomed Introducing Sets.
Device ID | K874771 |
510k Number | K874771 |
Device Name: | ANGIOMED INTRODUCING SETS |
Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
Contact | Michael Mccallum |
Correspondent | Michael Mccallum ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
Product Code | DWB |
CFR Regulation Number | 870.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-19 |
Decision Date | 1988-01-12 |