FDA.reportPublic FDA data

510(k) K833574

Device
Percutaneous Sheath Introducer Trays
Applicant
INTERMED, INC.
510(k) number
K833574
Product code
DQX
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-11
Date received
1983-10-12
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
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K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical2026-03-19
K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH2026-03-06
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K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.2026-01-09
K251596Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps2025-11-09
K250203SureAx-Guide™Sureax Medical, LLC2025-10-17
K250031Amplatzer GuidewireABBOTT MEDICAL2025-10-03