Synergy KIT-405-62
by Health Line International Corp
Synergy KIT-405-62 is a Class II device made by Health Line International Corp, cleared under FDA 510(k) K101329 on 19 Aug 2010 and listed in FDA GUDID since 31 Mar 2016 (UDI-DI 00876604000940), 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 | Number00876604000940 | Date31 Mar 2016 | StatusListed |
| United States | FDA 510(k) | NumberK101329 | Date19 Aug 2010 | StatusActive |
Official records
- AccessGUDID record 00876604000940
- FDA 510(k) database K101329
Across registries
- FDA 510(k) K101329 decided 19 Aug 2010 Active
- FDA GUDID UDI-DI 00876604000940 listed 31 Mar 2016 Listed
Timeline
- Cleared FDA 510(k) K101329
- Listed FDA GUDID 00876604000940
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Synergy
- Generic name
- Peripherally-inserted central venous catheter
- Model / reference
- KIT-405-62
- Primary DI / UDI-DI
- 00876604000940
- 510(k) Number
- FDA product code
- LJS
- GMDN term
- Peripherally-inserted central venous catheter
- Device class
- Class II
- Regulation number
- 880.5970
- GUDID distribution status
- In Commercial Distribution
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