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FDA 510(k), K984022, PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
FDA 510(k), K984022, PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
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510(K) Number: K984022
Device Name: PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
Manufacturer: ARROW INTL., INC.
Device Classification Name: catheter, hemodialysis, non-implanted
Regulation Number: 876.5540
Classification Product Code: MPB
Date Received: 11/12/1998
Decision Date: 05/18/1999
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
Manufacturer: ARROW INTL., INC.
Device Classification Name: catheter, hemodialysis, non-implanted
Regulation Number: 876.5540
Classification Product Code: MPB
Date Received: 11/12/1998
Decision Date: 05/18/1999
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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