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

STERILE HICHMAN/BROVIAC INJECTION CAP

K Number: K840846 · Decision Jul 6, 1984
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
6
Review Days
133

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Basic Information

Device Name
STERILE HICHMAN/BROVIAC INJECTION CAP
K Number
K840846
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5970
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Evermed, Inc.
Date Received
February 24, 1984
Decision Date
July 6, 1984
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

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (LJS), ordered by most recent decision date.

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Other Clearances by Evermed, Inc.

K Number Device Name
K840529 STEIGER TUNNELING INSTRUMENT 285
K830406 NON-STERILE CATHETER REPAIR KITS
K830256 NON-STERILE BROVIAC PARENTERAL ALIMI-
K830233 NON-STERILE,SINGLE/SOUBLE LUMEN-CATH
K830257 NON-STERILE PERITONEAL ACCESS CATHET-