Catheter, Intracardiac Mapping, High-Density, Reprocessed

NLG · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1220

Classification

FDA Product Code: NLG
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1220
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Market data

Cleared 510(k) submissions: 3
Registered establishments: 6

Source

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