| Device Type ID | 831 |
| Device Name | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Regulation Description | Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene. |
| 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) |
| CFR Regulation Number | 870.3470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 831 |
| Device | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Product Code | DXZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene. |
| CFR Regulation Number | 870.3470 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADMEDUS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AESCULAP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CELXCEL PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORMATRIX CARDIOVASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CRYOLIFE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 52 |
Insufficient Information | 34 |
Restricted Flow Rate | 32 |
Device Operates Differently Than Expected | 20 |
Material Rupture | 19 |
Material Distortion | 14 |
Device Contamination With Chemical Or Other Material | 14 |
Delamination | 14 |
Nonstandard Device | 9 |
Hole In Material | 7 |
Appropriate Term/Code Not Available | 7 |
Material Integrity Problem | 7 |
Material Split, Cut Or Torn | 6 |
Material Frayed | 5 |
Product Quality Problem | 4 |
Material Separation | 3 |
Material Deformation | 3 |
Material Erosion | 3 |
Device Markings / Labelling Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Crack | 2 |
Detachment Of Device Or Device Component | 2 |
Missing Information | 2 |
Migration Or Expulsion Of Device | 2 |
Material Puncture / Hole | 2 |
Loss Of Or Failure To Bond | 1 |
Device Dislodged Or Dislocated | 1 |
Physical Property Issue | 1 |
No Apparent Adverse Event | 1 |
Occlusion Within Device | 1 |
Patient-Device Incompatibility | 1 |
Torn Material | 1 |
Fluid Leak | 1 |
Microbial Contamination Of Device | 1 |
Partial Blockage | 1 |
Peeled / Delaminated | 1 |
Material Fragmentation | 1 |
Unsealed Device Packaging | 1 |
Off-Label Use | 1 |
| Total Device Problems | 281 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp. | II | Aug-12-2016 |
| 2 | CryoLife, Inc. | II | Oct-18-2018 |
| 3 | CryoLife, Inc. | II | Jun-21-2018 |
| 4 | CryoLife, Inc. | II | Jan-23-2014 |
| 5 | GETINGE US SALES LLC | II | Mar-20-2018 |
| 6 | Synovis Surgical Innovations, Inc. | I | May-29-2015 |