| Device Type ID | 882 |
| Device Name | Device, Percutaneous Retrieval |
| Regulation Description | Embolectomy Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MMX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 882 |
| Device | Device, Percutaneous Retrieval |
| Product Code | MMX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Embolectomy Catheter. |
| CFR Regulation Number | 870.5150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VASCULAR SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOLCANO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 20 |
Break | 12 |
Detachment Of Device Component | 7 |
Detachment Of Device Or Device Component | 4 |
Fracture | 4 |
Leak / Splash | 3 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Material Frayed | 1 |
Failure To Adhere Or Bond | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Slipped | 1 |
| Total Device Problems | 63 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | I | Aug-27-2014 |