| Device Type ID | 870 |
| Device Name | Catheter, Peripheral, Atherectomy |
| Regulation Description | Intraluminal Artery Stripper. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4875 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MCW |
| 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 | 870 |
| Device | Catheter, Peripheral, Atherectomy |
| Product Code | MCW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intraluminal Artery Stripper. |
| CFR Regulation Number | 870.4875 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ATHEROMED INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AVINGER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
BAYER MEDICAL CARE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIOVASCULAR SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
COVIDIEN, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDRAD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SPECTRANETICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRANETICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRANETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
STRAUB MEDICAL AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Catheter | 368 |
Adverse Event Without Identified Device Or Use Problem | 327 |
Entrapment Of Device | 294 |
Material Separation | 154 |
Detachment Of Device Or Device Component | 135 |
Material Deformation | 106 |
Aspiration Issue | 99 |
Device Operates Differently Than Expected | 67 |
Break | 62 |
Difficult To Remove | 48 |
Device Damaged By Another Device | 45 |
Mechanical Problem | 42 |
Fracture | 32 |
Suction Problem | 30 |
Detachment Of Device Component | 30 |
Guidewire | 22 |
Material Fragmentation | 19 |
Tip | 17 |
Shaft | 14 |
Mechanical Jam | 14 |
Device-Device Incompatibility | 14 |
Leak / Splash | 12 |
Difficult To Advance | 12 |
Use Of Device Problem | 11 |
Material Puncture / Hole | 11 |
Device Operational Issue | 10 |
Material Twisted / Bent | 10 |
Material Rupture | 10 |
Torn Material | 10 |
Noise, Audible | 10 |
Device Contamination With Chemical Or Other Material | 10 |
Retraction Problem | 9 |
Failure To Advance | 8 |
Material Integrity Problem | 8 |
Device Stops Intermittently | 7 |
Improper Or Incorrect Procedure Or Method | 7 |
Hole In Material | 7 |
Defective Device | 7 |
Difficult To Open Or Close | 6 |
Infusion Or Flow Problem | 5 |
Compatibility Problem | 4 |
Obstruction Of Flow | 4 |
Unintended System Motion | 4 |
Device Remains Activated | 4 |
Material Perforation | 4 |
Insufficient Information | 4 |
Kinked | 4 |
Unintended Movement | 4 |
Peeled / Delaminated | 3 |
Complete Blockage | 3 |
Intermittent Loss Of Power | 3 |
Unexpected Shutdown | 3 |
Device Packaging Compromised | 3 |
Positioning Problem | 3 |
Display Or Visual Feedback Problem | 3 |
Wire | 3 |
Deformation Due To Compressive Stress | 3 |
Material Split, Cut Or Torn | 3 |
Device Inoperable | 3 |
Physical Resistance | 3 |
Contamination During Use | 2 |
Defective Component | 2 |
Solder Joint Fracture | 2 |
Appropriate Term/Code Not Available | 2 |
Device Displays Incorrect Message | 2 |
Contamination / Decontamination Problem | 2 |
Electrical /Electronic Property Problem | 2 |
Material Frayed | 2 |
Fluid Leak | 2 |
Crack | 2 |
Failure To Shut Off | 2 |
Cut In Material | 2 |
Split | 2 |
Material Distortion | 2 |
Material Protrusion / Extrusion | 2 |
Positioning Failure | 2 |
Device Issue | 2 |
Failure To Power Up | 2 |
Off-Label Use | 2 |
Poor Quality Image | 2 |
Partial Blockage | 2 |
Incorrect Device Or Component Shipped | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Physical Resistance / Sticking | 1 |
Motor | 1 |
Knotted | 1 |
Sticking | 1 |
Device Remains Implanted | 1 |
Component Or Accessory Incompatibility | 1 |
Material Torqued | 1 |
Misassembly By Users | 1 |
Device Handling Problem | 1 |
Thermal Decomposition Of Device | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Loose Or Intermittent Connection | 1 |
Device Damaged Prior To Use | 1 |
Difficult Or Delayed Activation | 1 |
Blocked Connection | 1 |
Packaging Problem | 1 |
Nonstandard Device | 1 |
| Total Device Problems | 2240 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Boston Scientific Corporation | II | Apr-10-2017 |
| 2 | Cardiovascular Systems Inc | II | Oct-11-2018 |
| 3 | Cardiovascular Systems Inc | II | Apr-10-2017 |
| 4 | Cardiovascular Systems Inc | II | Apr-10-2017 |
| 5 | Cardiovascular Systems Inc | II | Feb-22-2017 |
| 6 | Cardiovascular Systems Inc | II | Jun-27-2016 |
| 7 | Cardiovascular Systems, Inc. | I | Aug-14-2014 |
| 8 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | II | Sep-11-2018 |
| 9 | Spectranetics Corp. | II | Feb-05-2016 |
| 10 | Spectranetics Corporation | II | Jul-14-2017 |
| 11 | Spectranetics Corporation | II | Nov-28-2016 |