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510(k) K032962

AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE by Arrow Intl., Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2003
Date Received
September 23, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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  • K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (April 6, 2006)
  • K042126 — PICC (August 27, 2004)
  • K041153 — SHARPSAWAY II LOCKING DISPOSABLE CUP (July 12, 2004)
  • K040801 — INTRA-AORTIC BALLOON (IAB) (May 6, 2004)
  • K040802 — HEMOSONIC 200HEMODYNAMIC MONITOR (April 28, 2004)

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