System, Balloon, Intra-Aortic And Control, Reprocessed

NKO · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.3535

Classification

FDA Product Code: NKO
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 870.3535
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 2
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: 0
Registered establishments: 0

Source

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