The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. D/b/a Estech with the FDA for Estech Easyflow Cannula With Guidewire.
| Device ID | K091542 |
| 510k Number | K091542 |
| Device Name: | ESTECH EASYFLOW CANNULA WITH GUIDEWIRE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 San Ramon, CA 94583 |
| Contact | Tamer Ibrahim |
| Correspondent | Tamer Ibrahim ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH 2603 CAMINO RAMON SUITE 100 San Ramon, CA 94583 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-26 |
| Decision Date | 2009-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622136365 | K091542 | 000 |
| 10803622128070 | K091542 | 000 |
| 10803622124195 | K091542 | 000 |
| 10803622124188 | K091542 | 000 |
| 10803622147309 | K091542 | 000 |
| 10803622147279 | K091542 | 000 |
| 10803622147996 | K091542 | 000 |