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FDA 510(k) Application Details - K211410
Device Classification Name
Catheter, Hemodialysis, Implanted
More FDA Info for this Device
510(K) Number
K211410
Device Name
Catheter, Hemodialysis, Implanted
Applicant
Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, AZ 85281 US
Other 510(k) Applications for this Company
Contact
Joan Bergstrom
Other 510(k) Applications for this Contact
Regulation Number
876.5540
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Classification Product Code
MSD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2021
Decision Date
06/04/2021
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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