FDA product code GBA: Catheter, Balloon Type
GBA is the FDA product code for catheter, balloon type. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under GBA, from 5 different applicants. The average 510(k) review took 74 days (median 78). FDA has posted 1 recall for GBA devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Balloon Type |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GBA clearance
Top GBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Byron Medical | 1 | 1986-05-30 |
| Loseff Medical Designers, Ltd. | 1 | 1980-09-26 |
| Electro-Catheter Corp. | 1 | 1979-06-11 |
| Medi-Tech, Inc. | 1 | 1979-03-06 |
| National Catheter Co. Div. Mallinckrodt | 1 | 1978-12-15 |
Most recent GBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K861877 | Byron Medical | BYRON WORD BARTHOLIAN GLAND CATHETER | 1986-05-30 | 15 |
| K802025 | Loseff Medical Designers, Ltd. | BALLOON RETENTION CHEST CATHETER | 1980-09-26 | 37 |
| K790444 | Electro-Catheter Corp. | ELECATH MULTI-PURPOSE ARTERIAL SURGER | 1979-06-11 | 97 |
| K781772 | Medi-Tech, Inc. | CATHETER, TRANSLUMINAL BALLOON | 1979-03-06 | 141 |
| K781665 | National Catheter Co. Div. Mallinckrodt | TUBE, LEATHERMAN/IMBRUCE | 1978-12-15 | 78 |
Recalls for GBA devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-31.
Frequently asked questions
What is FDA product code GBA?
GBA is the FDA product code for catheter, balloon type. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GBA?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBA?
Across 5 cleared submissions the average was 74 days from receipt to decision (median 78).
Which companies have the most GBA clearances?
Byron Medical (1); Loseff Medical Designers, Ltd. (1); Electro-Catheter Corp. (1); Medi-Tech, Inc. (1); National Catheter Co. Div. Mallinckrodt (1).
Have GBA devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code GBA
- Run a recall and safety report across every GBA manufacturer
- Watch product code GBA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times