Definition: For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
| Device Type ID | 925 |
| Device Name | Catheter, Ultrasound, Intravascular |
| Physical State | Catheter With Ultrasound Sensors That Is Used With An Imaging System To Display Ultrasound Image. |
| Technical Method | Catheter With Ultrasound Sensors That Is Used With An Imaging System To Display Ultrasound Image. |
| Target Area | Cardiovascular Anatomy And Physiology. |
| Regulation Description | Diagnostic Intravascular Catheter. |
| 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 | 870.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 925 |
| Device | Catheter, Ultrasound, Intravascular |
| Product Code | OBJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACIST MEDICAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACIST MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSENSE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSENSE WEBSTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SIEMENS CAPITAL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SIEMENS MEDICAL SOLUTIONS USA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOLCANO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Catheter | 604 |
Retraction Problem | 461 |
Motor Drive Unit | 305 |
Material Separation | 199 |
Entrapment Of Device | 197 |
No Display / Image | 174 |
Adverse Event Without Identified Device Or Use Problem | 111 |
Poor Quality Image | 90 |
Use Of Device Problem | 66 |
Detachment Of Device Component | 56 |
Shaft | 51 |
Wireless Communication Problem | 50 |
Difficult To Remove | 34 |
Detachment Of Device Or Device Component | 32 |
Tip | 31 |
Break | 28 |
Fracture | 23 |
Device Displays Incorrect Message | 20 |
False Device Output | 16 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 15 |
Failure To Advance | 15 |
Material Deformation | 14 |
Output Problem | 13 |
Improper Device Output | 12 |
Device Contamination With Chemical Or Other Material | 11 |
Physical Resistance | 10 |
Device Operational Issue | 9 |
Unable To Obtain Readings | 9 |
Kinked | 9 |
Insufficient Information | 8 |
Peeled / Delaminated | 8 |
Material Fragmentation | 7 |
Material Protrusion / Extrusion | 7 |
Torn Material | 7 |
Fluid Leak | 7 |
Positioning Problem | 7 |
Erratic Or Intermittent Display | 7 |
Device Sensing Problem | 7 |
Device Operates Differently Than Expected | 5 |
Material Split, Cut Or Torn | 5 |
Signal Artifact | 5 |
Difficult To Advance | 5 |
Difficult To Open Or Remove Packaging Material | 5 |
Display Or Visual Feedback Problem | 5 |
Unsealed Device Packaging | 4 |
Incorrect Interpretation Of Signal | 3 |
Hole In Material | 3 |
Unexpected Shutdown | 3 |
Device Issue | 3 |
Device Packaging Compromised | 3 |
Device-Device Incompatibility | 3 |
Crack | 3 |
Material Puncture / Hole | 3 |
Connection Problem | 3 |
Material Integrity Problem | 3 |
Contamination During Use | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Compatibility Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Inappropriate Or Unexpected Reset | 2 |
Delivered As Unsterile Product | 2 |
Syringe | 2 |
Bags | 2 |
Loss Of Or Failure To Bond | 2 |
Degraded | 2 |
Appropriate Term/Code Not Available | 2 |
Overheating Of Device | 2 |
Difficult To Insert | 2 |
Transducer | 2 |
Leak / Splash | 2 |
Device Emits Odor | 2 |
False Negative Result | 1 |
Off-Label Use | 1 |
Folded | 1 |
Device Damaged By Another Device | 1 |
Out-Of-Box Failure | 1 |
Mechanical Jam | 1 |
Image Display Error / Artifact | 1 |
Electrical Shorting | 1 |
Sticking | 1 |
Physical Resistance / Sticking | 1 |
Flaked | 1 |
Malposition Of Device | 1 |
Ambient Noise Problem | 1 |
Device Markings / Labelling Problem | 1 |
Loose Or Intermittent Connection | 1 |
Difficult To Position | 1 |
Defective Device | 1 |
Device Or Device Fragments Location Unknown | 1 |
Flushing Problem | 1 |
No Device Output | 1 |
Transmitter | 1 |
No Apparent Adverse Event | 1 |
Component Missing | 1 |
Failure To Calibrate | 1 |
Deformation Due To Compressive Stress | 1 |
Activation, Positioning Or Separation Problem | 1 |
Difficult To Flush | 1 |
Seal | 1 |
| Total Device Problems | 2858 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Arrow International Inc | II | Nov-28-2017 |
| 3 | Arrow International Inc | II | May-26-2017 |
| 4 | Arrow International Inc | II | Aug-31-2015 |
| 5 | Arrow International Inc | III | Jan-29-2015 |
| 6 | Biosense Webster, Inc. | II | Oct-01-2015 |
| 7 | VasoNova, Inc. | II | Apr-09-2015 |
| 8 | Volcano Corporation | II | Jan-11-2019 |
| 9 | Volcano Corporation | II | Nov-29-2017 |
| 10 | Volcano Corporation | II | Apr-10-2017 |
| 11 | Volcano Corporation | II | May-25-2016 |
| 12 | Volcano Corporation | II | Jun-25-2015 |