The following data is part of a premarket notification filed by Microvena Corp. with the FDA for The Big Easy Y-adapter.
| Device ID | K914046 |
| 510k Number | K914046 |
| Device Name: | THE BIG EASY Y-ADAPTER |
| Classification | Introducer, Catheter |
| Applicant | MICROVENA CORP. 3600 LABORE RD. #1 Vadnais Heights, MN 55110 |
| Contact | Rudy Mazzocchi |
| Correspondent | Rudy Mazzocchi MICROVENA CORP. 3600 LABORE RD. #1 Vadnais Heights, MN 55110 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1991-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684058060 | K914046 | 000 |
| 00821684058053 | K914046 | 000 |