Catheter, Balloon Type
The Catheter, Balloon Type (product code GBA) is a catheter with an inflatable balloon at its distal end, used during general or plastic surgery procedures for dilation, occlusion, or controlled placement within body lumens or cavities. It is classified as FDA Class 1, the lowest risk level, subject to general controls only and not requiring premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GBA
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | May 30, 1986 | Substantially Equivalent | Byron Medical |
| K802025 | BALLOON RETENTION CHEST CATHETER | Sep 26, 1980 | Substantially Equivalent | Loseff Medical Designers, Ltd. |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | Jun 11, 1979 | Substantially Equivalent | Electro-Catheter Corp. |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Mar 06, 1979 | Substantially Equivalent | Medi-Tech, Inc. |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | Dec 15, 1978 | Substantially Equivalent | National Catheter Co. Div. Mallinckrodt |
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.