| Device Type ID | 809 |
| Device Name | Instruments, Surgical, Cardiovascular |
| Regulation Description | Cardiovascular Surgical Instruments. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.4500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DWS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 809 |
| Device | Instruments, Surgical, Cardiovascular |
| Product Code | DWS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cardiovascular Surgical Instruments. |
| CFR Regulation Number | 870.4500 [🔎] |
| Device Problems | |
|---|---|
Break | 33 |
Mechanical Jam | 24 |
Suction Problem | 20 |
Mechanical Problem | 11 |
Misfire | 9 |
Failure To Cut | 7 |
Difficult To Open Or Close | 7 |
Delivered As Unsterile Product | 6 |
Contamination / Decontamination Problem | 6 |
Activation, Positioning Or Separation Problem | 5 |
Difficult To Remove | 5 |
Entrapment Of Device | 5 |
Sticking | 5 |
Detachment Of Device Or Device Component | 4 |
Fracture | 4 |
Material Separation | 3 |
Physical Resistance / Sticking | 2 |
Insufficient Information | 2 |
Material Integrity Problem | 2 |
No Apparent Adverse Event | 2 |
Appropriate Term/Code Not Available | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Fail-Safe Problem | 1 |
Material Frayed | 1 |
Device Displays Incorrect Message | 1 |
Failure To Eject | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
Component Missing | 1 |
Metal Shedding Debris | 1 |
Product Quality Problem | 1 |
Device Reprocessing Problem | 1 |
Device Operates Differently Than Expected | 1 |
Temperature Problem | 1 |
Crack | 1 |
Moisture Damage | 1 |
Positioning Problem | 1 |
Crank Arm Assembly | 1 |
Dent In Material | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Handling Problem | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
| Total Device Problems | 187 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biorep Technologies | II | May-02-2014 |
| 2 | Cincinnati Sub-Zero Products Inc | II | Nov-22-2016 |
| 3 | Genesee BioMedical, Inc. | II | May-29-2018 |
| 4 | International Biophysics Corp. | II | Aug-19-2015 |