SecurePortIV SP-015V50
SecurePortIV SP-015V50 is a wearable percutaneous catheter/tube holder (FDA Class II; FDA product code NZP, Sealant, Microbial) made by Adhezion Biomedical, LLC, cleared under FDA 510(k) K170505 on 29 Sep 2017 and listed in FDA GUDID since 2 Apr 2018 (UDI-DI M495SP015V502), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM495SP015V502 | Date2 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170505 | Date29 Sep 2017 | StatusActive |
Official records
- FDA 510(k) database K170505
Across registries
- FDA 510(k) K170505 decided 29 Sep 2017 Active
- FDA GUDID UDI-DI M495SP015V502 listed 2 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K170505
- Listed FDA GUDID M495SP015V502
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SecurePortIV
- Generic name
- Wearable percutaneous catheter/tube holder, single-use
- Model / Ref / Catalog
- SP-015V50
- Primary DI / UDI-DI
- M495SP015V502
- 510(k) Number
- FDA product code
- NZP
- GMDN term
- Wearable percutaneous catheter/tube holder, single-use
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — .15 Milliliter
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