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

Accessories, Catheter

21 CFR 878.4200 / General, Plastic Surgery
FDA source (opens on fda.gov)

KGZ is the FDA product code for Accessories, Catheter, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
KGZ
Device name
Accessories, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
29
Ingested recalls
23

Clearances, product code KGZ

By decision year
29 clearances under product code KGZ with a decision year between 1976 and 2002, 1976 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KGZ by decision year
YearClearances
19763
19771
19783
19793
19802
19812
19822
19841
19862
19872
19893
19941
19961
19982
20021

Applicants with the most clearances

Product code KGZ
Applicants holding the most 510(k) clearances under product code KGZ
ApplicantClearances
B. Braun Instruments3
Arrow Intl., Inc.2
Conphar, Inc.2
Quinton, Inc.2
Warner-Lambert Co.2
Aesthetic and Reconstructive Technologies, Inc.1
Allied Biomedical Corp.1
American Viggo1
Angiomed U.S., Inc.1
Argon Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 173 companies shown, in name order