The following data is part of a premarket notification filed by Magnolia Medical Technologies, Inc. with the FDA for Steripath Gen2 Blood Collection System.
| Device ID | K192247 |
| 510k Number | K192247 |
| Device Name: | Steripath Gen2 Blood Collection System |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle, WA 98119 |
| Contact | Gregory J Bullington |
| Correspondent | John Ray Magnolia Medical Technologies, Inc. 200 West Mercer Street Suite 500 Seattle, WA 98119 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858366007313 | K192247 | 000 |
| 10858366007051 | K192247 | 000 |
| 10858366007006 | K192247 | 000 |
| 10858366007174 | K192247 | 000 |
| 10858366007167 | K192247 | 000 |
| 10858366007143 | K192247 | 000 |
| 10858366007136 | K192247 | 000 |
| 10858366007129 | K192247 | 000 |
| 10858366007112 | K192247 | 000 |
| 00858366007276 | K192247 | 000 |
| 00858366007306 | K192247 | 000 |
| 00858366007290 | K192247 | 000 |
| 00858366007283 | K192247 | 000 |
| 10858366007204 | K192247 | 000 |
| 10858366007198 | K192247 | 000 |
| 10858366007044 | K192247 | 000 |
| 10858366007037 | K192247 | 000 |
| 10858366007020 | K192247 | 000 |
| 00858366007016 | K192247 | 000 |
| 10858366007150 | K192247 | 000 |