The following data is part of a premarket notification filed by Kalera Medical, Inc. with the FDA for Kalera Vacuum Aspiration Catheter (k-vac).
| Device ID | K200419 |
| 510k Number | K200419 |
| Device Name: | Kalera Vacuum Aspiration Catheter (K-VAC) |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Kalera Medical, Inc. 13240 Evening Creek Drive S., Suite 304 San Diego, CA 92128 |
| Contact | Jee Shin |
| Correspondent | Diane Horwitz Mandell Horwitz Consultants, LLC 5 Lake Como Ct. Greenville, SC 29609 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2020-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20860005357707 | K200419 | 000 |