Product code GBA
- Device name
- Catheter, Balloon Type
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | Byron Medical | 1986-05-30 |
| K802025 | BALLOON RETENTION CHEST CATHETER | Loseff Medical Designers, Ltd. | 1980-09-26 |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | Electro-Catheter Corp. | 1979-06-11 |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Medi-Tech, Inc. | 1979-03-06 |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | National Catheter Co. Div. Mallinckrodt | 1978-12-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860014541704 | Envision | SPINAL STABILIZATION TECHNOLOGIES LIMITED | 2026-04-30 |
| 00860014541711 | Envision | SPINAL STABILIZATION TECHNOLOGIES LIMITED | 2026-04-30 |
| 06979032640031 | GOBEN | HUZHOU JUNDA INDUSTRY CO., LTD. | 2025-08-26 |
| M7403150006 | Verify | SPINEOLOGY INC. | 2023-06-26 |
| 00887482173718 | Symmetry Surgical® | ASPEN SURGICAL PRODUCTS, INC. | 2022-09-21 |
| 00678467506849 | Mui Scientific | H & A Mui Enterprises Inc | 2019-05-06 |
| 04048551007662 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551051764 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551098363 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551098387 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551098448 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551272237 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 44026704306204 | RUSCH | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704306206 | RUSCH | TELEFLEX INCORPORATED | 2018-09-15 |
| 00678467006882 | Mui Scientific | H & A Mui Enterprises Inc | 2018-08-28 |
| 00678467006325 | Mui Scientific | H & A Mui Enterprises Inc | 2018-08-28 |
| 00678467006370 | Mui Scientific | H & A Mui Enterprises Inc | 2018-08-28 |
| 00678467006691 | Mui Scientific | H & A Mui Enterprises Inc | 2018-08-28 |
| 00678467006141 | Mui Scientific | H & A Mui Enterprises Inc | 2018-08-27 |
| 00678467005953 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-27 |
| 00678467005960 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-27 |
| 00678467005977 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-27 |
| 00678467005984 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-27 |
| 00678467005854 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-26 |
| 00678467005908 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-26 |
| 00678467005342 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-24 |
| 00678467005564 | Mui Scientific | H & A Mui Enterprises Inc | 2018-07-24 |
| 00815849022072 | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | 2016-11-21 |
| 08714729195450 | Pneumatic Inflator | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 60888937003248 | CooperSurgical, Inc. | Coopersurgical, Inc. | 2016-09-15 |