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

LYMPHANGIOGRAPHY SET

K Number: K830576 · Decision Mar 17, 1983
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
21
Review Days
22

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Basic Information

Device Name
LYMPHANGIOGRAPHY SET
K Number
K830576
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Vertex Medical Corp.
Date Received
February 23, 1983
Decision Date
March 17, 1983
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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Other Clearances by Vertex Medical Corp.

K Number Device Name
K833742 ESCHMANN DILATION CATHETER
K834476 NEPHROSTOMY/BILIARY DRAINAGE BAG
K832380 PROTECTIVE SLEEVE
K831666 SIALOGRAPHY NEEDLE
K830420 POLYETHYLENE MONITORING CONNECTORS
K830237 TRANSLUCENT POLY. CATH. CONNECTOR AND
K823192 TUOHY-BORST ADAPTER W/SIDE ARM
K823253 VERTEX MONITORING CATHETER
K823256 ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
K823254 REUSABLE METAL STOPCOCK
Search all 21 clearances from Vertex Medical Corp. →