The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. with the FDA for Estech Aortic Easy Flow Cannula.
Device ID | K060101 |
510k Number | K060101 |
Device Name: | ESTECH AORTIC EASY FLOW CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | ENDOSCOPIC TECHNOLOGIES, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
Contact | Craig Coombs |
Correspondent | Craig Coombs ENDOSCOPIC TECHNOLOGIES, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-12 |
Decision Date | 2006-05-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10803622128063 | K060101 | 000 |
10803622125826 | K060101 | 000 |
10803622124171 | K060101 | 000 |
10803622147156 | K060101 | 000 |
10803622147293 | K060101 | 000 |