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510(k) K071998

ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT by Arrow Intl., Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2007
Date Received
July 23, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Arrow Intl., Inc.

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  • K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES (October 10, 2007)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)
  • 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)
  • K040100 — ARROW ECHOGENIC INTRODUCER NEEDLE (March 1, 2004)

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