The following data is part of a premarket notification filed by Estech, Inc. with the FDA for Remote Access Perfusion (rap) Femoral Venous Cannula.
| Device ID | K052081 |
| 510k Number | K052081 |
| Device Name: | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | ESTECH, INC. 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs ESTECH, 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 | 2005-08-02 |
| Decision Date | 2005-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622128100 | K052081 | 000 |
| 10803622128094 | K052081 | 000 |
| 10803622128087 | K052081 | 000 |
| 10803622125819 | K052081 | 000 |
| 10803622125802 | K052081 | 000 |
| 10803622125796 | K052081 | 000 |
| 10803622147149 | K052081 | 000 |
| 10803622147217 | K052081 | 000 |
| 10803622147286 | K052081 | 000 |