Centermark PICC Insertion Tray Landmark Midline Catheter Prep Tray
510(k) K945521
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945521 | Date6 Apr 1995 | 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- Withdrawn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
- Full name
- Centermark(R) Picc Insertion Tray Landmark(R) Midline Catheter Prep Tray
- 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, 19 Sep 2026
This device is a Catheter, Intravascular, Therapeutic, Short-term (Less Than 30 Days) designed for the preparation and insertion of peripherally inserted central catheter (PICC) lines. It provides a sterile, organized workspace for assembling midline catheters, including pre-measured tubing, connectors, and dressing supplies to facilitate proper placement and secure attachment in clinical settings.
The tray is intended for single-use in hospital or outpatient environments, ensuring aseptic conditions during catheter preparation. Supplied sterile and packaged for procedural use, it adheres to FDA 510(k) clearance (K945521) under product code FOZ, with no third-party certification noted. Storage requires adherence to manufacturer guidelines to maintain sterility prior to use.