The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Smart Occluder Lh (left-hand), Quantum Smart Occluder Lh (right-hand).
| Device ID | K190282 |
| 510k Number | K190282 |
| Device Name: | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl2 9ql |
| Contact | Colleen Powell |
| Correspondent | Colleen Powell Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl2 9ql |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-05-24 |