AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
FDA 510(k) clearance K982657 · decided 1998-11-18
Clearance details
- K-number
- K982657
- Device name
- AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
- Applicant
- Microvena Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-30
- Decision date
- 1998-11-18
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- White Bear Lake, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.