The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Multiflow Roller Pump Module.
Device ID | K861714 |
510k Number | K861714 |
Device Name: | STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE |
Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Contact | Morton Barak |
Correspondent | Morton Barak SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
Product Code | DWB |
CFR Regulation Number | 870.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-05 |
Decision Date | 1986-07-16 |