Home / 510(k) Clearances / K040802

510(k) K040802

HEMOSONIC 200HEMODYNAMIC MONITOR by Arrow Intl., Inc. — Product Code DPN

K040802 is an FDA 510(k) premarket notification submitted by Arrow Intl., Inc. for the device "HEMOSONIC 200HEMODYNAMIC MONITOR". The FDA issued a decision of Substantially Equivalent on April 28, 2004. The device falls under product code DPN (Thin Layer Chromatography, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Arrow Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2004
Date Received
March 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Propoxyphene
Device Class
Class II
Regulation Number
862.3700
Review Panel
TX
Submission Type

Other clearances by Arrow Intl., Inc.

  • K100635 — ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) (August 27, 2010)
  • 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)
  • K040100 — ARROW ECHOGENIC INTRODUCER NEEDLE (March 1, 2004)

FDA data resources