Search Results
Found 2 results
510(k) Data Aggregation
K Number
K011860Device Name
KEYST0NE MEDICAL PICC CATHETER
Manufacturer
Date Cleared
2001-06-27
(13 days)
Product Code
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
KEYSTONE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.
Device Description
Single or double lumen intravenous catheters. Devices will be assembled in a kit that includes components that are either legally marketed; exempt from premarket requirements; or "grandfathered".
Ask a Question
Ask a specific question about this device
K Number
K001958Device Name
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH
Manufacturer
Date Cleared
2000-09-25
(90 days)
Product Code
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
KEYSTONE MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
Page 1 of 1