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

CONTINUOUS FLUSH DEVICE

K Number: K792141 · Decision Dec 5, 1979
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
170
Applicant Total
24
Review Days
44

Basic Information

Device Name
CONTINUOUS FLUSH DEVICE
K Number
K792141
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1210
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
Date Received
October 22, 1979
Decision Date
December 5, 1979
Product Code
KRA
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

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

Product Code Device Name
KRA Catheter, Continuous Flush

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