The following data is part of a premarket notification filed by Microvena Corp. with the FDA for The Amplatz Thrombectomy Device.
| Device ID | K954205 |
| 510k Number | K954205 |
| Device Name: | THE AMPLATZ THROMBECTOMY DEVICE |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Contact | Jodi Locher |
| Correspondent | Jodi Locher MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-07 |
| Decision Date | 1996-08-13 |
| Summary: | summary |