Product code GCE
- Device name
- Adaptor, Catheter
- 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#
Related GUDID Devices#
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|---|---|---|---|
| 04044503008145 | FUJIFILM medwork | FUJIFILM medwork GmbH | 2026-03-31 |
| 16932503562253 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2025-04-30 |
| 06932503562256 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2025-04-30 |
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| 00860003054918 | CLR Port | CLR Medical | 2024-05-29 |
| 00860003054956 | CLR Port | CLR Medical | 2024-05-29 |
| 00850052377007 | CLR Port Injector | CLR Medical | 2024-05-29 |
| 00850052377014 | CLR Port Cap | CLR Medical | 2024-05-29 |
| 10887709078014 | ICU Medical | ICU MEDICAL, INC. | 2023-08-30 |
| 00887709078017 | ICU Medical | ICU MEDICAL, INC. | 2023-08-30 |
| 00887709078024 | ICU Medical | ICU MEDICAL, INC. | 2023-08-30 |
| 10887709078021 | ICU Medical | ICU MEDICAL, INC. | 2023-08-30 |
| 00827002226777 | COOK | COOK INCORPORATED | 2022-12-08 |
| 00827002226760 | COOK | COOK INCORPORATED | 2022-12-08 |
| 06932503562249 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562300 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562294 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562287 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562270 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562263 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562232 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562225 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 06932503562218 | Spray Catheter | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-31 |
| 00801741050046 | Cardiothoracic Adaptor | C. R. Bard, Inc. | 2020-09-22 |
| 00860002576640 | Maveric Medical | MAVERIC MEDICAL LLC | 2020-07-30 |
| 00860002576626 | Maveric Medical LLC | MAVERIC MEDICAL LLC | 2019-10-28 |
| 08053323800026 | 175IBLSSC | ELCAM MEDICAL ITALY SPA | 2019-02-26 |
| 28053323800020 | 175IBLSSC | ELCAM MEDICAL ITALY SPA | 2019-02-26 |
| 00858293006014 | RPC | REPROCESSING PRODUCTS CORPORATION | 2017-03-07 |