Abbott Vascular-Cardiac Therapies: FDA clearances and approvals
Abbott Vascular-Cardiac Therapies has 6 FDA 510(k) clearances (first 2010, latest 2011), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time: 70 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 3 | 3 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 | 3 |
| NIO | Stent, Iliac | 1 | 0 |
Review panels
- Cardiovascular (7)
Most recent Abbott Vascular-Cardiac Therapies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112957 | HI-TORQUE POWERTURN | DQX | 2011-11-08 | 35 |
| K110134 | NC TREK RX CORONARY DILATATION CATHETER | LOX | 2011-02-11 | 24 |
| K103101 | HI-TORQUE BALANCE MIDDLEWEIGHT ELITE | DQX | 2011-02-10 | 113 |
| K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | LOX | 2011-01-10 | 94 |
| K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | LOX | 2010-12-30 | 77 |
| K101116 | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH | DQX | 2010-06-23 | 63 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110043 | PMA | OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM | 2012-07-31 |
Recalls
openFDA lists no recalls under a recalling firm named Abbott Vascular-Cardiac Therapies.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Abbott Vascular-Cardiac Therapies's product codes (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances does Abbott Vascular-Cardiac Therapies have?
Abbott Vascular-Cardiac Therapies has 6 FDA 510(k) clearances (first 2010, latest 2011), plus 1 PMA decision, across 3 product codes in 1 review panel.
How long does FDA take to clear Abbott Vascular-Cardiac Therapies's 510(k)s?
The median time from FDA receipt to decision across Abbott Vascular-Cardiac Therapies's cleared 510(k)s is 70 days.
What devices does Abbott Vascular-Cardiac Therapies make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 3); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 3); NIO (Stent, Iliac, 1).
Has Abbott Vascular-Cardiac Therapies had device recalls?
openFDA lists no recalls under a recalling firm name matching Abbott Vascular-Cardiac Therapies. Related entities may recall under other names.
Next steps
- See all 6 Abbott Vascular-Cardiac Therapies clearances with predicates and recalls
- Run predicate analysis for product code DQX, Abbott Vascular-Cardiac Therapies's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.