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510(k) K041153

SHARPSAWAY II LOCKING DISPOSABLE CUP by Arrow Intl., Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2004
Date Received
May 3, 2004
Clearance Type
Traditional
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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  • K093050 — ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 (December 18, 2009)
  • K071491 — ARROW INTERNATIONAL, INC., SURGICAL DRAPES (October 10, 2007)
  • K071998 — ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT (September 26, 2007)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)
  • K060309 — AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES (April 6, 2006)
  • K042126 — PICC (August 27, 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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