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

Catheter, Infusion

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

JCY is the FDA product code for Catheter, Infusion, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
JCY
Device name
Catheter, Infusion
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
14
Ingested recalls
3

Clearances, product code JCY

By decision year
14 clearances under product code JCY with a decision year between 1976 and 1986, 1976 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code JCY by decision year
YearClearances
19765
19771
19791
19821
19833
19842
19861

Applicants with the most clearances

Product code JCY
Applicants holding the most 510(k) clearances under product code JCY
ApplicantClearances
B. Braun Instruments4
Argon Medical Corp.2
American Heyer Schulte1
Jelco Laboratories1
Medical Components, Inc.1
Quest Medical, Inc1
Sherwood Medical Industries1
Superior Plastic Products Corp.1
Travenol Laboratories, S.A.1
Vas-Cath of Canada, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order