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Synergy A14-04150

by Health Line International Corp

Synergy A14-04150 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 9 Mar 2016 (UDI-DI 00876604000773), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K101329

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00876604000773 UDI-DI Date9 Mar 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK101329 Date19 Aug 2010IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101329 decided 19 Aug 2010 Active
  • FDA GUDID UDI-DI 00876604000773 listed 9 Mar 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101329
  2. Listed FDA GUDID 00876604000773

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Synergy
Generic name
Peripherally-inserted central venous catheter
Model / reference
A14-04150
Primary DI / UDI-DI
00876604000773
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

Similar devices

Other devices filed under FDA product code LJS (Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days).

Other devices from Health Line International Corp

See all devices from Health Line International Corp →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)