510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LKGClass II

Port & Catheter, Implanted, Subcutaneous, Intraventricular

21 CFR 882.5550 / Neurology
FDA source (opens on fda.gov)

LKG is the FDA product code for Port & Catheter, Implanted, Subcutaneous, Intraventricular, a class II device type, regulated under 21 CFR 882.5550. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LKG
Device name
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Regulation
21 CFR 882.5550
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code LKG

By decision year
8 clearances under product code LKG with a decision year between 1983 and 1995, 1988 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LKG by decision year
YearClearances
19831
19842
19884
19951

Applicants with the most clearances

Product code LKG
Applicants holding the most 510(k) clearances under product code LKG
ApplicantClearances
Pudenz-Schulte Medical Research Corp.3
Pharmacia Deltec, Inc.2
American Heyer Schulte1
Cordis US Corp.1
Holter-Hausner Intl.1

Companies listing this code with FDA

Companies whose registered establishments list this code