FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MONITORING LINES & FLUID ADMIN.

K Number: K771387 · Decision Aug 22, 1977
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
63
Applicant Total
39
Review Days
26

Basic Information

Device Name
MONITORING LINES & FLUID ADMIN.
K Number
K771387
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5440
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
NORTON PERFORMANCE PLASTICS CORP.
Date Received
July 27, 1977
Decision Date
August 22, 1977
Product Code
FPK
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
FPK Tubing, Fluid Delivery

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K851299 CORRECT FLO
K842858 FLUID ADMINISTRATION LINE W/SPIKE 14-923
K841828 CENTRAL VENOUS CATHETER W/BIG-GARD
K840240 MICROFUSE INTRAVENOUS CATHETER SET
K831587 TEMP. REPAIR KIT-DUAL LUMEN CATHETER
K831698 DISPOSABLE PRESSURE TRANSDUCER#14004195
K830788 CENTRAL VEIN CATHERIZATION KIT-14-690-
K830813 FRENCH PERCUTANEOUS SHEATH INTRODUCER
Search all 39 clearances from NORTON PERFORMANCE PLASTICS CORP. →