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

CENTRAL VEIN CATHETERIZATION KIT

K Number: K800741 · Decision Apr 16, 1980
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
63
Review Days
13

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Basic Information

Device Name
CENTRAL VEIN CATHETERIZATION KIT
K Number
K800741
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Medical Components, Inc.
Date Received
April 3, 1980
Decision Date
April 16, 1980
Product Code
DQO
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
DQO Catheter, Intravascular, Diagnostic

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K Number Device Name
K250836 14F Duo-Flow® Side X Side Double Lumen Catheter
K141633 PRO-PICC WITH VALVE TECHNOLOGY
K132880 MEDCOMP POWER INJECTABLE SAFETY HUBER NEEDLE
K131687 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
K130687 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130923 5F DIGNITY CT TITANIUM PORT
K124046 VALVED TEARAWAY INTRODUCER GENERATION II
K123617 3F PRO-PICC
K122423 VASU-PICC
K121848 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
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