← FDA Medical Device Classifications
Catheter, Hemodialysis, Triple Lumen, Non-Implanted
NIE · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5540
Classification
- FDA Product Code
NIE- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 876.5540
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- Y
- Implant
- N
- Third-party review
- N
Definition
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Market data
- Cleared 510(k) submissions
- 12
- Registered establishments
- 20
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown