Stabilizer, Heart, Non-Compression, Reprocessed

NQG · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.4500

Classification

FDA Product Code: NQG
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 870.4500
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. 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: 1

Source

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