The following data is part of a premarket notification filed by Q Core Medical Ltd with the FDA for Sapphire Administration Set.
| Device ID | K141834 |
| 510k Number | K141834 |
| Device Name: | SAPPHIRE ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | Q CORE MEDICAL LTD 12154 Darnestown Road, #236 Gaithersburg, MD 20878 |
| Contact | Rhona Shanker |
| Correspondent | Rhona Shanker Q CORE MEDICAL LTD 12154 Darnestown Road, #236 Gaithersburg, MD 20878 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290109150479 | K141834 | 000 |
| 27290109150387 | K141834 | 000 |
| 27290109150370 | K141834 | 000 |
| 27290109150363 | K141834 | 000 |
| 27290109159236 | K141834 | 000 |