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510(k) Data Aggregation
K Number
K961155Device Name
SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
Manufacturer
Date Cleared
1996-06-18
(88 days)
Product Code
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
DOUGLAS MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SoloPak Peripheral Intravenous Catheter Insertion Kits are intended to be used for the placement of a peripheral catheter.
Device Description
The SoloPak Peripheral Intravenous Catheter Insertion Kits include a single lumen catheter, introducer, and the necessary accessories to perform the placement.
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K Number
K954428Device Name
SOLOPICC 24 (60CM) 20GA CATHETER
Manufacturer
Date Cleared
1996-03-28
(188 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
DOUGLAS MEDICAL PRODUCTS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SoloPICC and SoloMidline Peripheral Intravenous catheters are intended to be used for the administration of medications, fluids and nutritional therapy of thirty days or less duration.
Device Description
The SoloPICC and SoloMidline catheters are sterile, non-pvrogenic, single lumen radiopaque catheters with a PVC female Luer lock adapter. A stiffening stylet is inserted into the female adapter and runs the length of the catheter. The catheter is shrouded in a polyethylene protector and packaged in a printed tyvek\mylar peel pouch. A TFX T-Peelтм peelable introducer catheter is included in the tyvek\mylar package for catheter insertion purposes.
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