The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Amplatz Thrombectomy Device(atd 603,602,801,802)/foot Pedal Assembly(ak 200).
| Device ID | K971984 |
| 510k Number | K971984 |
| Device Name: | AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Contact | Janell Colley |
| Correspondent | Janell Colley 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 | 1997-05-29 |
| Decision Date | 1997-09-19 |
| Summary: | summary |