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510(k) K021120

RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP by Arrow Intl., Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2002
Date Received
April 8, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
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)
  • 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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