Cardion™ PP1015
by Acell, Inc.
Cardion™ PP1015 is a Class II device made by Acell, Inc., cleared under FDA 510(k) K191734 on 22 Nov 2019 and listed in FDA GUDID since 31 Jul 2020 (UDI-DI 00386190002087), 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 | Number00386190002087 | Date31 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191734 | Date22 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 00386190002087
- FDA 510(k) database K191734
Across registries
- FDA 510(k) K191734 decided 22 Nov 2019 Active
- FDA GUDID UDI-DI 00386190002087 listed 31 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K191734
- Listed FDA GUDID 00386190002087
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cardion™
- Generic name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
- Model / Ref / Catalog
- PP1015
- Primary DI / UDI-DI
- 00386190002087
- 510(k) Number
- FDA product code
- PSQ
- GMDN term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
- Device class
- Class II
- Regulation number
- 870.3470
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Length — 15 CentimeterWidth — 10 Centimeter