Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K190282 |
Device Name |
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) |
Applicant |
Spectrum Medical Ltd |
Harrier 4, Meteor Business Park, Cheltenham Road East |
Gloucester,
GB
GL2 9QL
|
|
Applicant Contact |
Colleen Powell |
Correspondent |
Spectrum Medical Ltd |
Harrier 4, Meteor Business Park, Cheltenham Road East |
Gloucester,
GB
GL2 9QL
|
|
Correspondent Contact |
Colleen Powell |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 02/11/2019 |
Decision Date | 05/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|