← FDA Medical Device Classifications
Balloon Aortic Valvuloplasty
OZT · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1255
Classification
- FDA Product Code
OZT- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.1255
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Market data
- Cleared 510(k) submissions
- 21
- Registered establishments
- 22
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown