Electrode, Pacing And Cardioversion, Temporary, Epicardial

NHW · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3680

Classification

FDA Product Code: NHW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.3680
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.

Market data

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

Source

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