Device Type ID | 5690 |
Device Name | Catheter, Infusion |
Regulation Description | Introduction/drainage Catheter And Accessories. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 878.4200 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JCY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5690 |
Device | Catheter, Infusion |
Product Code | JCY |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Introduction/drainage Catheter And Accessories. |
CFR Regulation Number | 878.4200 [🔎] |
Device Problems | |
---|---|
Insufficient Information | 1 |
Material Integrity Problem | 1 |
Connection Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 4 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | DePuy Mitek, Inc., A Johnson & Johnson Co. | II | Feb-23-2018 |