| Device Type ID | 772 |
| Device Name | System, Balloon, Intra-aortic And Control |
| Regulation Description | Intra-aortic Balloon And Control System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3535 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DSP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 772 |
| Device | System, Balloon, Intra-aortic And Control |
| Product Code | DSP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intra-aortic Balloon And Control System. |
| CFR Regulation Number | 870.3535 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARROW INTL., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DATASCOPE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Device Alarm System | 459 |
Device Operates Differently Than Expected | 345 |
Fluid Leak | 318 |
Device Displays Incorrect Message | 250 |
Material Rupture | 167 |
Gas Leak | 133 |
Leak / Splash | 110 |
Inflation Problem | 109 |
Difficult To Insert | 98 |
Pumping Stopped | 80 |
No Display / Image | 55 |
Communication Or Transmission Problem | 49 |
Difficult To Advance | 49 |
Connection Problem | 41 |
Adverse Event Without Identified Device Or Use Problem | 38 |
Balloon | 38 |
Kinked | 38 |
Occlusion Within Device | 37 |
Failure To Zero | 35 |
Difficult To Remove | 34 |
Battery Problem | 31 |
Low Battery | 25 |
Unable To Obtain Readings | 23 |
Device Contamination With Body Fluid | 20 |
Failure To Advance | 20 |
Physical Resistance | 20 |
Entrapment Of Device | 19 |
Device Sensing Problem | 18 |
Device-Device Incompatibility | 16 |
Crack | 15 |
Material Puncture / Hole | 15 |
Deformation Due To Compressive Stress | 14 |
No Apparent Adverse Event | 14 |
Detachment Of Device Component | 14 |
Break | 13 |
Display Or Visual Feedback Problem | 12 |
Power Problem | 11 |
Failure To Pump | 10 |
Use Of Device Problem | 10 |
Aspiration Issue | 10 |
Device Contamination With Chemical Or Other Material | 9 |
Loose Or Intermittent Connection | 9 |
Difficult To Flush | 9 |
Failure To Calibrate | 9 |
Migration Or Expulsion Of Device | 8 |
Erratic Or Intermittent Display | 8 |
Failure To Unfold Or Unwrap | 8 |
No Device Output | 7 |
Noise, Audible | 7 |
Failure To Sense | 7 |
Alarm, Audible | 6 |
Difficult To Interrogate | 6 |
Smoking | 6 |
Premature Discharge Of Battery | 6 |
Backflow | 6 |
Pressure Problem | 6 |
Device Emits Odor | 6 |
Material Separation | 5 |
Device Handling Problem | 5 |
Material Deformation | 5 |
Detachment Of Device Or Device Component | 5 |
Inadequate User Interface | 5 |
Volume Accuracy Problem | 5 |
Obstruction Of Flow | 5 |
Device Inoperable | 5 |
Bent | 5 |
Failure To Read Input Signal | 4 |
Charging Problem | 4 |
Failure To Run On Battery | 4 |
Invalid Sensing | 4 |
Application Program Freezes, Becomes Nonfunctional | 4 |
Blocked Connection | 4 |
Calibration Problem | 4 |
Mechanical Problem | 4 |
Insufficient Information | 4 |
Fitting Problem | 4 |
Image Display Error / Artifact | 4 |
Partial Blockage | 4 |
Hole In Material | 4 |
Inability To Auto-Fill | 4 |
Failure To Power Up | 3 |
Computer Operating System Problem | 3 |
Pumping Problem | 3 |
Antenna, Failure Of | 3 |
Sensing Intermittently | 3 |
Device Misassembled During Manufacturing / Shipping | 3 |
Torn Material | 3 |
Failure To Run On AC/DC | 3 |
Malfunction | 3 |
Moisture Or Humidity Problem | 3 |
Rupture, Cause Unknown | 3 |
Increase In Pressure | 3 |
Appropriate Term/Code Not Available | 3 |
Inadequate Instructions For Healthcare Professional | 3 |
No Audible Alarm | 3 |
Signal Artifact | 3 |
Defective Component | 3 |
Burst Container Or Vessel | 3 |
Pre Or Post-Pumping Problem | 3 |
Human-Device Interface Problem | 3 |
| Total Device Problems | 3097 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | Mar-10-2015 |
| 2 | Arrow International Inc | II | Mar-02-2015 |
| 3 | Arrow International, Inc., Division Of Teleflex Medical Inc. | I | Mar-11-2016 |
| 4 | Datascope Corporation | II | Oct-11-2018 |
| 5 | Datascope Corporation | II | Apr-16-2018 |
| 6 | Datascope Corporation | II | Jun-08-2016 |
| 7 | Datascope Corporation | III | Sep-03-2014 |
| 8 | Maquet Datascope Corp - Cardiac Assist Division | I | Oct-27-2018 |
| 9 | Maquet Datascope Corp - Cardiac Assist Division | I | May-31-2018 |
| 10 | Maquet Datascope Corp - Cardiac Assist Division | I | Sep-05-2017 |
| 11 | Maquet Datascope Corp - Cardiac Assist Division | I | Jun-23-2017 |
| 12 | Maquet Datascope Corp - Cardiac Assist Division | II | Mar-02-2017 |
| 13 | Maquet Datascope Corp - Cardiac Assist Division | II | Mar-25-2016 |
| 14 | Maquet Datascope Corp - Cardiac Assist Division | II | Feb-23-2015 |
| 15 | Maquet Datascope Corp - Cardiac Assist Division | II | Feb-07-2015 |
| 16 | Maquet Datascope Corp - Cardiac Assist Division | I | May-21-2014 |