The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intersept 1375 Venous Reservoir.
Device ID | K903632 |
510k Number | K903632 |
Device Name: | INTERSEPT 1375 VENOUS RESERVOIR |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Contact | Norma L Lowe |
Correspondent | Norma L Lowe MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-08-10 |
Decision Date | 1990-12-17 |