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FDA 510(k), K122581, MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
FDA 510(k), K122581, MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
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510(K) Number: K122581
Device Name: MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
Manufacturer: CONCENTRIC MEDICAL, INC.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 08/23/2012
Decision Date: 11/21/2012
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
Manufacturer: CONCENTRIC MEDICAL, INC.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 08/23/2012
Decision Date: 11/21/2012
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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