← FDA Medical Device Classifications
Kit, Balloon Repair, Catheter
DQP · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.1350
Classification
- FDA Product Code
DQP- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 870.1350
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown