The following data is part of a premarket notification filed by Adhezion Biomedical, Llc with the FDA for Secureportiv Catheter Securement Adhesive.
| Device ID | K170505 |
| 510k Number | K170505 |
| Device Name: | SecurePortIV Catheter Securement Adhesive |
| Classification | Sealant, Microbial |
| Applicant | Adhezion Biomedical, LLC One Meridian Blvd - Suite 1B02 Wyomissing, PA 19610 |
| Contact | Richard G. Jones |
| Correspondent | Richard G. Jones Adhezion Biomedical, LLC One Meridian Blvd - Suite 1B02 Wyomissing, PA 19610 |
| Product Code | NZP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M495SP015V502 | K170505 | 000 |
| M495SP015V2 | K170505 | 000 |
| M495SP015V1 | K170505 | 000 |