| Device Type ID | 812 |
| Device Name | Clamp, Vascular |
| Regulation Description | Vascular Clamp. |
| 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 | 870.4450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXC |
| 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 | 812 |
| Device | Clamp, Vascular |
| Product Code | DXC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vascular Clamp. |
| CFR Regulation Number | 870.4450 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED VASCULAR DYNAMICS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AROSURGICAL INSTRUMENTS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COMBAT MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVATIVE TRAUMA CARE INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MARINE POLYMER TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC VASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SYMMETRY SURGICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fitting Problem | 229 |
Seal | 192 |
Air Leak | 119 |
Positioning Failure | 81 |
Mechanical Problem | 44 |
Device Contamination With Chemical Or Other Material | 42 |
Adverse Event Without Identified Device Or Use Problem | 40 |
Crack | 30 |
Leak / Splash | 25 |
Device Operates Differently Than Expected | 25 |
Appropriate Term/Code Not Available | 24 |
Break | 24 |
Detachment Of Device Component | 23 |
Insufficient Information | 22 |
Load | 20 |
Gas Leak | 15 |
Difficult To Open Or Close | 14 |
Misfire | 12 |
Migration Or Expulsion Of Device | 12 |
Cutter | 10 |
Balloon | 9 |
Device Displays Incorrect Message | 8 |
Loss Of Or Failure To Bond | 8 |
Suction Problem | 7 |
Material Rupture | 7 |
Hole In Material | 6 |
Deflation Problem | 6 |
Unraveled Material | 6 |
Bent | 6 |
Inflation Problem | 5 |
Device Operational Issue | 5 |
Pressure Problem | 5 |
Fluid Leak | 5 |
Device Slipped | 4 |
Device Issue | 4 |
Failure To Fire | 4 |
Misconnection | 3 |
Valve | 3 |
Device Deployer | 3 |
Failure To Adhere Or Bond | 3 |
Tip | 3 |
Use Of Device Problem | 3 |
Material Separation | 3 |
Decrease In Pressure | 3 |
Material Deformation | 3 |
Premature Activation | 3 |
Dull, Blunt | 3 |
Loose Or Intermittent Connection | 2 |
Positioning Problem | 2 |
Packaging Problem | 2 |
Sticking | 2 |
Unintended Movement | 2 |
Off-Label Use | 2 |
Device Packaging Compromised | 2 |
Activation, Positioning Or Separation Problem | 2 |
Component Missing | 2 |
Structural Problem | 2 |
Difficult Or Delayed Positioning | 2 |
Delivered As Unsterile Product | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Burst Container Or Vessel | 2 |
Device Reprocessing Problem | 1 |
Fracture | 1 |
Infusion Or Flow Problem | 1 |
Unstable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Discolored | 1 |
False Alarm | 1 |
Increase In Pressure | 1 |
Self-Activation Or Keying | 1 |
Wire | 1 |
Syringe | 1 |
Cannula | 1 |
Failure To Cut | 1 |
Incorrect Measurement | 1 |
Melted | 1 |
Device Difficult To Setup Or Prepare | 1 |
Material Puncture / Hole | 1 |
Human Factors Issue | 1 |
Mechanical Jam | 1 |
Plunger | 1 |
Application Program Problem | 1 |
Computer Operating System Problem | 1 |
Inadequate Or Insufficient Training | 1 |
Complete Blockage | 1 |
Tube | 1 |
Spring | 1 |
Thread | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Material Perforation | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
Improper Flow Or Infusion | 1 |
Component Falling | 1 |
Malposition Of Device | 1 |
Difficult To Advance | 1 |
Mechanics Altered | 1 |
| Total Device Problems | 1196 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Edwards Lifesciences, LLC | II | May-24-2018 |
| 2 | Edwards Lifesciences, LLC | II | Jun-11-2015 |
| 3 | Merit Medical Systems, Inc. | II | Apr-10-2017 |
| 4 | Sam Medical Products | II | Dec-16-2014 |