Ideas Dual Port
510(k) K962751
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962751 | Date30 Sep 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5965
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Ideas Dual Port is a totally implantable system designed to provide repeated access to the vascular system. It is categorized as an implanted, subcutaneous, intravascular port and catheter device used for the infusion of medications.
This device is regulated under FDA 510(k) clearance K962751. It is intended for use in a general hospital setting.