Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position

OMF · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5970

Classification

FDA Product Code: OMF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5970
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown