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FDA 510(k), K180722, CAPERE Thrombectomy System
FDA 510(k), K180722, CAPERE Thrombectomy System
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510(K) Number: K180722
Device Name: CAPERE Thrombectomy System
Manufacturer: KP Medcure, Inc.
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 03/19/2018
Decision Date: 06/11/2018
Regulation Medical Specialty: Cardiovascular
Device Name: CAPERE Thrombectomy System
Manufacturer: KP Medcure, Inc.
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: 870.5150
Classification Product Code: QEW
Date Received: 03/19/2018
Decision Date: 06/11/2018
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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