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 |