The following data is part of a premarket notification filed by Biowy Corporation with the FDA for Biowy Picc Catheter S Kit.
| Device ID | K192246 |
| 510k Number | K192246 |
| Device Name: | Biowy PICC Catheter S Kit |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Biowy Corporation 27031/27002 Vista Terrace Lake Forest, CA 92630 |
| Contact | Arthur Lu |
| Correspondent | Arthur Lu Biowy Corporation 27031/27002 Vista Terrace Lake Forest, CA 92630 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2020-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851739007163 | K192246 | 000 |
| 00851739007156 | K192246 | 000 |