← FDA Medical Device Classifications
Intracardiac Patch Or Pledget, Biologically Derived
PSQ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3470
Classification
- FDA Product Code
PSQ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.3470
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Market data
- Cleared 510(k) submissions
- 11
- Registered establishments
- 21
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown