FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH

K Number: K926331 · Decision Mar 7, 1994
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
21
Review Days
446

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Basic Information

Device Name
3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH
K Number
K926331
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5970
Medical Specialty
General Hospital
Decision
Unknown
Statement or Summary
Summary
Applicant
Bard Access Systems, Inc.
Date Received
December 16, 1992
Decision Date
March 7, 1994
Product Code
LJS
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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K241353 PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set
K242328 PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports
K240146 BD Prevue™ II Peripheral Vascular Access System
K222232 Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
K210264 BD PowerPiCC Catheter
K120882 SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
K100402 SITE-RITE VISION ULTRASOUND SYSTEM
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