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 |