Balloon Applicator 720846
by Icad, Inc.
Balloon Applicator 720846 (AB2070) is a Class II device made by Icad, Inc., cleared under FDA 510(k) K090914 on 16 Jul 2009 and listed in FDA GUDID since 5 Nov 2019 (UDI-DI 00858012005984), active as of 22 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 | Number00858012005984 | Date5 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESU | NumberK090914 | Date16 Jul 2009 | StatusActive |
Official records
- AccessGUDID record 00858012005984
- FDA 510(k) database K090914
Across registries
- FDA 510(k) K090914 decided 16 Jul 2009 Active
- FDA GUDID UDI-DI 00858012005984 listed 5 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K090914
- Listed FDA GUDID 00858012005984
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Balloon Applicator
- Generic name
- Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
- Model / Ref / Catalog
- 720846, AB2070
- Primary DI / UDI-DI
- 00858012005984
- 510(k) Number
- FDA product code
- JAD
- GMDN term
- Intraoperative/postoperative therapeutic x-ray system balloon applicator kit
- Device class
- Class II
- Regulation number
- 892.5900
- GUDID distribution status
- In Commercial Distribution
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