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FDA 510(k), K111943, AGILLS PF DELIVERY SYSTEM
FDA 510(k), K111943, AGILLS PF DELIVERY SYSTEM
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510(K) Number: K111943
Device Name: AGILLS PF DELIVERY SYSTEM
Manufacturer: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
Device Classification Name: Introducer, Catheter
Regulation Number: 870.1340
Classification Product Code: DYB
Date Received: 07/08/2011
Decision Date: 09/29/2011
Regulation Medical Specialty: Cardiovascular
Device Name: AGILLS PF DELIVERY SYSTEM
Manufacturer: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
Device Classification Name: Introducer, Catheter
Regulation Number: 870.1340
Classification Product Code: DYB
Date Received: 07/08/2011
Decision Date: 09/29/2011
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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