The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Amplatz Goose-neck Snare.
| Device ID | K901502 |
| 510k Number | K901502 |
| Device Name: | AMPLATZ GOOSE-NECK SNARE |
| Classification | Catheter, Embolectomy |
| Applicant | MICROVENA CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MICROVENA CORP. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-29 |
| Decision Date | 1990-12-03 |