AccuCath BC Intravascular Catheter System
510(k) K140504
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140504 | Date17 Jul 2014 | 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- Withdrawn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
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The AccuCath BC Intravascular Catheter System is a vascular access device classified as an intravascular catheter (Product Code: FOZ). It is designed for intravascular use to facilitate blood sampling, blood pressure monitoring, and intravenous fluid administration. The system is intended for insertion into a patient’s vascular system, ensuring reliable vascular access for therapeutic or diagnostic procedures. Its construction supports compatibility with low-pressure power injectors and consideration of vascular anatomy, infusion solution, and therapy duration.
This device is supplied as a sterile, single-use catheter system and is regulated under FDA 510(k) clearance (K140504). It is intended for use in clinical settings such as general hospitals, adhering to standard aseptic techniques. The system is not MRI-safe and must be handled according to manufacturer guidelines for storage and preparation. No additional regulatory approvals beyond the stated 510(k) clearance are implied.