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

Catheter, Balloon Type

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

GBA is the FDA product code for Catheter, Balloon Type, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GBA
Device name
Catheter, Balloon Type
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
5
Ingested recalls
1

Clearances, product code GBA

By decision year
5 clearances under product code GBA with a decision year between 1978 and 1986, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GBA by decision year
YearClearances
19781
19792
19801
19861

Applicants with the most clearances

Product code GBA
Applicants holding the most 510(k) clearances under product code GBA
ApplicantClearances
Byron Medical1
Electro-Catheter Corp.1
Loseff Medical Designers, Ltd.1
Medi-Tech, Inc.1
National Catheter Co. Div. Mallinckrodt1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order