| Device Type ID | 764 |
| Device Name | Cable, Transducer And Electrode, Patient, (including Connector) |
| Regulation Description | Patient Transducer And Electrode Cable (including Connector). |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DSA |
| 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 | 764 |
| Device | Cable, Transducer And Electrode, Patient, (including Connector) |
| Product Code | DSA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Patient Transducer And Electrode Cable (including Connector). |
| CFR Regulation Number | 870.2900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION 2200 INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAREFUSION 303, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CURBELL MEDICAL PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UNIMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VOLCANO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Cable | 15 |
Device Operates Differently Than Expected | 9 |
Connection Problem | 6 |
Sparking | 5 |
Material Integrity Problem | 4 |
Output Problem | 3 |
Failure Of Device To Self-Test | 2 |
Failure To Capture | 2 |
Device Inoperable | 2 |
Smoking | 2 |
Intermittent Continuity | 1 |
Failure To Interrogate | 1 |
Device Displays Incorrect Message | 1 |
Defective Component | 1 |
Over-Sensing | 1 |
Communication Or Transmission Problem | 1 |
Arcing | 1 |
Electrical Shorting | 1 |
Failure To Power Up | 1 |
Device Packaging Compromised | 1 |
Break | 1 |
Charred | 1 |
No Device Output | 1 |
Defective Device | 1 |
Intermittent Capture | 1 |
Loose Or Intermittent Connection | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 67 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Remington Medical Inc. | II | Apr-09-2014 |