Definition: A PTCA Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
| Device Type ID | 865 |
| Device Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Regulation Description | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. |
| 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 | 870.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LOX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 865 |
| Device | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Product Code | LOX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. |
| CFR Regulation Number | 870.5100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN INTERVENTIONAL SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOTRONIK GMBG & CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOTRONIK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BROSMED MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KANEKA CORP | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
KANEKA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDINOL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIL LIFE SCIENCES PRIVATE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NATEC MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTIAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRIREME MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRIREME MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Material Rupture | 2781 |
Balloon | 2450 |
Break | 732 |
Shaft | 702 |
Catheter | 560 |
Failure To Advance | 548 |
Difficult To Remove | 324 |
Adverse Event Without Identified Device Or Use Problem | 237 |
Deflation Problem | 218 |
Burst Container Or Vessel | 215 |
Inflation Problem | 150 |
Leak / Splash | 131 |
Material Separation | 127 |
Detachment Of Device Component | 126 |
Improper Or Incorrect Procedure Or Method | 126 |
Entrapment Of Device | 119 |
Difficult To Advance | 102 |
Detachment Of Device Or Device Component | 98 |
Kinked | 83 |
Device Damaged Prior To Use | 72 |
Material Deformation | 66 |
Hole In Material | 47 |
Tip | 33 |
Device Contamination With Chemical Or Other Material | 30 |
Deformation Due To Compressive Stress | 25 |
Difficult To Position | 24 |
Difficult To Open Or Remove Packaging Material | 23 |
Fracture | 20 |
Physical Resistance | 15 |
Material Integrity Problem | 14 |
Defective Device | 14 |
Unsealed Device Packaging | 14 |
Device Damaged By Another Device | 14 |
Device Handling Problem | 13 |
Torn Material | 13 |
Device Markings / Labelling Problem | 13 |
Material Puncture / Hole | 13 |
Failure To Fold | 13 |
Material Perforation | 11 |
Physical Resistance / Sticking | 11 |
Device Issue | 10 |
Positioning Problem | 10 |
Use Of Device Problem | 10 |
Activation, Positioning Or Separation Problem | 10 |
Material Split, Cut Or Torn | 10 |
Physical Property Issue | 9 |
Difficult To Insert | 9 |
Stretched | 8 |
Bent | 8 |
Sticking | 7 |
Off-Label Use | 6 |
Device Expiration Issue | 6 |
Device Dislodged Or Dislocated | 6 |
Label | 6 |
Contamination / Decontamination Problem | 5 |
Mechanical Problem | 5 |
Device Slipped | 5 |
Component Or Accessory Incompatibility | 4 |
Peeled / Delaminated | 4 |
Component Missing | 4 |
Incorrect Measurement | 4 |
Device Operational Issue | 4 |
Patient-Device Incompatibility | 3 |
Product Quality Problem | 3 |
Defective Component | 3 |
Stent | 3 |
Retraction Problem | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Device-Device Incompatibility | 3 |
Device Packaging Compromised | 3 |
Hub | 3 |
Loose Or Intermittent Connection | 2 |
Material Distortion | 2 |
Nonstandard Device | 2 |
Fluid Leak | 2 |
Insufficient Information | 2 |
Human Factors Issue | 2 |
Material Protrusion / Extrusion | 2 |
Folded | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Seal | 2 |
Protector | 2 |
Device Contamination With Body Fluid | 2 |
Guidewire | 2 |
Device Operates Differently Than Expected | 2 |
Calcified | 1 |
Human-Device Interface Problem | 1 |
Material Twisted / Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Contamination During Use | 1 |
Compatibility Problem | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Biofilm Coating In Device | 1 |
Difficult Or Delayed Positioning | 1 |
Material Frayed | 1 |
Occlusion Within Device | 1 |
Unintended System Motion | 1 |
Component Misassembled | 1 |
Luer Valve | 1 |
IOL (Intraocular Lens) Implant | 1 |
| Total Device Problems | 10547 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Vascular | I | May-12-2017 |
| 2 | Cordis Corporation | II | Aug-28-2014 |
| 3 | Cordis Corporation | II | Jun-11-2014 |
| 4 | Medtronic Vascular Galway DBA Medtronic Ireland | II | Sep-20-2017 |