Product code GCC
- Device name
- Dilator, 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#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | Med Institute, Inc. | 1998-05-26 |
| K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | Med Institute, Inc. | 1992-07-30 |
| K902502 | BYRD STAINLESS STEEL DILATOR | Medical Engineering and Development Institute | 1990-08-07 |
| K893480 | BYRD EXTRACTOR SET | Medical Engineering and Development Institute | 1989-06-23 |
| K820865 | VAN-TEC FASCIAL DILATOR | Van-Tec, Inc. | 1982-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450440483 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440476 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440599 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440582 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440575 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440568 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440537 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440520 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440513 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| 00884450440506 | Byrd | Merit Medical Systems, Inc. | 2026-08-21 |
| B382SD916130120 | Surgical Direct | Surgical Direct, Inc. | 2026-07-28 |
| 00810212933566 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933559 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933542 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933535 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930411 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933528 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933511 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212933504 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930459 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930442 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930435 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930428 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 00810212930404 | SURGIPROS | Surgipros, LLC | 2026-05-28 |
| 07613327459203 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 07613327459197 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 07613327459180 | AXS INFINITY LS PLUS | Stryker Corporation | 2018-10-08 |
| 08714729295846 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-19 |
| 08714729295860 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-19 |
| 08714729295884 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-19 |