510(k) Report

FDA applicant

Abbott Vascular-Cardiac Therapies

Temecula, CA7 decisions2010–201220 recalls

FDA records 7 decisions for Abbott Vascular-Cardiac Therapies (Temecula, CA) from 2010 to 2012: 6 510(k) clearances and 1 original PMA approval. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and DQX (Wire, Guide, Catheter). Its devices cite 8 predicates, 1 of them its own earlier devices. 20 recalls are linked to its devices, 20 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Abbott Vascular-Cardiac Therapies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 22011: 42012: 1
2010high 4 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

17in 2020

2017: 3, 3 Class I2020: 17, 17 Class I
2010high 17 (2020) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Abbott Vascular-Cardiac Therapies by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abbott Vascular-Cardiac Therapies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous3decisions
  • DQXWire, Guide, Catheter3decisions
  • NIOStent, Iliac1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 20114cite it
  • K110134NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 20113cite it
  • K103153Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 20102cite it
  • K103110Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw…Abbott Vascular-Cardiac Therapies · 20112cite it
  • K101116HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide…Abbott Vascular-Cardiac Therapies · 20102cite it
  • K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 20112cite it

What has FDA decided for it lately?

  • P110043Omnilink Elite Peripheral Balloon-Expandable Stent SystemAbbott Vascular-Cardiac Therapies · 2012
  • K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies · 2011
  • K110134NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 201117 Class I recalls
  • K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies · 2011
  • K103110Mini Trek (TM) RX and Trek (TM) RX Coronary Dilatation Catheter Mini Trek (TM) Otw and Trek (TM) Otw…Abbott Vascular-Cardiac Therapies · 2011
  • K103153Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation CatheterAbbott Vascular-Cardiac Therapies · 201020 Class I recalls
  • K101116HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide…Abbott Vascular-Cardiac Therapies · 2010

All 7 as Abbott Vascular-Cardiac Therapies →

What has been recalled?

20 recalls linked to its devices; the latest:

  • K103153NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC…Jan 29, 2020Class I
  • K103153NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC…Jan 29, 2020Class I
  • K103153NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC…Jan 29, 2020Class I
  • K103153NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC…Jan 29, 2020Class I
  • K103153NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC…Jan 29, 2020Class I
  • K103153NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC…Jan 29, 2020Class I

Other applicant names beginning “Abbott”

FDA records each applicant name separately; these may or may not be the same firm.

Abbott Laboratories 920Abbott Medical 92Abbott Vascular 64Abbott Diabetes Care, Inc. 42Abbott Molecular, Inc. 33Abbott Diagnostics 28Abbott Point of Care, Inc. 22Abbott Medical Optics, Inc. 16Abbott Mfg., Inc. 14Abbott 14Abbott Spine, Inc. 13Abbott Diagnostics Scarborough, Inc. 8