Data / Medical devices / United States / Abbott Vascular
Abbott Vascular: FDA-registered device maker in Barceloneta, PR, United States, 9 510(k) clearances
Abbott Vascular is registered with the FDA (registration 3005737652) in Barceloneta, PR, United States. It lists 1 device type. The FDA files 9 510(k) clearances under its listings, the newest dated November 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005737652
- Address
- Building PR-17, Road #2, km 58.0, Cruce Davila, Barceloneta, PR, United States, 00617
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- November 4, 2008
- Registered through
- 2026
- Brand names listed
- H-Torque Balance Middleweight Guide Wire, HT Command 14 MT, HT Command 14 ST, Hi-Torque BMW Universal II, Hi-Torque BMW Universal II Guide Wire, Hi-Torque Balance Guide Wire, Hi-Torque Balance HeavyWeight Guide Wire, Hi-Torque Balance Meddleweight Universal II Guide Wire and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2024 | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | DQX | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| January 12, 2018 | K173795 | HI-TORQUE TurnTrac Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| October 21, 2015 | K152709 | HI-TORQUE BALANCE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 7, 2014 | K141782 | HI-TORQUE VERSATURN GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| January 29, 2013 | K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| November 20, 2012 | K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| July 8, 2010 | K101648 | HI-TORQUE WINN GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| June 23, 2010 | K101116 | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| April 11, 2008 | K072460 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.