FDA.reportPublic FDA data

510(k) K810675

Device
ARROW RADIAL ARTERY CATHETERIZATION SET
Applicant
ARROW INTL., INC.
510(k) number
K810675
Product code
DQX  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-27
Date received
1981-03-12
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DQX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH2026-03-06
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K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.2026-01-09
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K250203SureAx-Guide™Sureax Medical, LLC2025-10-17
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K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)Merit Medical Ireland, Ltd.2025-08-29
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireABBOTT MEDICAL2025-07-25
K250075Medtronic Stedi Extra Support GuidewireMedtronic, Inc.2025-06-13