Device Type ID | 1894 |
Device Name | Clamp, Cannula |
Regulation Description | Blood Access Device And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | Gastroenterology/Urology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 876.5540 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FKC |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1894 |
Device | Clamp, Cannula |
Product Code | FKC |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Blood Access Device And Accessories. |
CFR Regulation Number | 876.5540 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Leak / Splash | 1 |
Total Device Problems | 3 |