The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model Ak 100.
| Device ID | K982657 |
| 510k Number | K982657 |
| Device Name: | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Contact | Tonya Weigel |
| Correspondent | Tonya Weigel 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 | 1998-07-30 |
| Decision Date | 1998-11-18 |
| Summary: | summary |