| Device Type ID | 869 |
| Device Name | Syringe, Balloon Inflation |
| Regulation Description | Angiographic Injector And Syringe. |
| 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 | 870.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MAV |
| 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 | 869 |
| Device | Syringe, Balloon Inflation |
| Product Code | MAV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic Injector And Syringe. |
| CFR Regulation Number | 870.1650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VASCULAR SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
| Device Problems | |
|---|---|
Gauges/Meters | 158 |
Device Packaging Compromised | 109 |
Inaccurate Information | 108 |
Incorrect Measurement | 107 |
Display Or Visual Feedback Problem | 65 |
Device Contamination With Chemical Or Other Material | 58 |
Tear, Rip Or Hole In Device Packaging | 46 |
Leak / Splash | 27 |
Label | 21 |
Device Damaged Prior To Use | 16 |
Break | 13 |
Packaging Problem | 13 |
Improper Device Output | 12 |
Device Operates Differently Than Expected | 12 |
Inflation Problem | 8 |
Detachment Of Device Component | 8 |
Pressure Problem | 6 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Delivered As Unsterile Product | 5 |
Material Puncture / Hole | 5 |
Crack | 5 |
Unable To Obtain Readings | 5 |
Fitting Problem | 4 |
Seal | 4 |
Misconnection | 3 |
Material Separation | 3 |
Fluid Leak | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Detachment Of Device Or Device Component | 2 |
Insufficient Information | 2 |
Physical Resistance / Sticking | 2 |
Device Contaminated During Manufacture Or Shipping | 2 |
Unstable | 2 |
Deflation Problem | 2 |
Suction Problem | 2 |
Balloon | 2 |
Increase In Pressure | 2 |
Contamination / Decontamination Problem | 1 |
Occlusion Within Device | 1 |
Cuff | 1 |
Catheter | 1 |
Appropriate Term/Code Not Available | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Guidewire | 1 |
Contamination During Use | 1 |
Display Difficult To Read | 1 |
Difficult To Remove | 1 |
Fracture | 1 |
No Pressure | 1 |
Decrease In Pressure | 1 |
Device Issue | 1 |
Air Leak | 1 |
Unsealed Device Packaging | 1 |
Noise, Audible | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Calibration Problem | 1 |
No Device Output | 1 |
Material Rupture | 1 |
Connector | 1 |
Housing | 1 |
Difficult To Insert | 1 |
Device Markings / Labelling Problem | 1 |
| Total Device Problems | 876 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Vascular | II | Feb-27-2019 |
| 2 | Boston Scientific Corporation | II | Aug-16-2017 |
| 3 | DeRoyal Industries Inc | II | Jun-29-2017 |
| 4 | Medtronic Vascular | III | Feb-26-2014 |
| 5 | Merit Medical Systems, Inc. | II | Oct-03-2016 |
| 6 | PEROUSE MEDICAL | II | Apr-28-2017 |
| 7 | PEROUSE MEDICAL | II | Dec-29-2014 |
| 8 | Perouse Medical | II | Jul-22-2014 |
| 9 | Vascular Solutions, Inc. | II | May-31-2017 |