Abbott Vascular: FDA filings under this applicant name
FDA lists 50 510(k) clearances under the applicant name “Abbott Vascular” (first 2000, latest 2022), plus 14 PMA decisions, across 19 product codes in 3 review panels. Median 510(k) review time under this name: 65 days. Since 2017 the median was 38 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 89 |
| 2013 | 2 | 110 |
| 2014 | 3 | 36 |
| 2015 | 4 | 28 |
| 2016 | 1 | 19 |
| 2017 | 2 | 38 |
| 2018 | 2 | 130 |
| 2019 | 2 | 57 |
| 2020 | 2 | 52 |
| 2021 | 0 | — |
| 2022 | 2 | 71 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Abbott Vascular took a median 38 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 19 | 19 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 8 | 6 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 7 | 7 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 4 | 4 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DRA | Catheter, Steerable | 3 | 3 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 3 | 3 |
| MAF | Stent, Coronary | 3 | 0 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| NIM | Stent, Carotid | 2 | 0 |
Plus 9 more product codes.
Review panels
Most recent Abbott Vascular 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220634 | NC TREK NEO Coronary Dilatation Catheter | LOX | 2022-06-30 | 118 |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | LIT | 2022-05-05 | 24 |
| K201834 | HI-TORQUE PROCEED Guide Wire Family | DQX | 2020-07-30 | 28 |
| K200144 | HI-TORQUE Steelcore Bare Guide Wire | DQX | 2020-04-08 | 77 |
| K193126 | HI-TORQUE InfilTrac Guide Wire Family | DQX | 2019-12-11 | 29 |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | NTE | 2019-07-25 | 85 |
| K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter; TREK RX Coronary Dilatation Catheter; TREK OTW Coronary Dilatation Catheter; MINI TREK RX Coronary Dilatation Catheter; MINI TREK OTW Coronary Dilatation Catheter; MINI TREK II OTW Coronary Dilatation Catheter | LOX | 2018-08-24 | 231 |
| K173795 | HI-TORQUE TurnTrac Guide Wire Family | DQX | 2018-01-12 | 29 |
| K172394 | Steerable Guide Catheter | DRA | 2017-09-06 | 29 |
| K172073 | Hi-Torque Command 18 Guide Wire | DQX | 2017-08-25 | 46 |
40 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P150023 | PMA | ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM | 2016-07-05 |
| P110028 | PMA | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM | 2012-02-22 |
| P110019 | PMA | Xience Skypoint Everolimus Eluting Coronary Stent System | 2011-11-01 |
| P110001 | PMA | RX HERCULINK ELITE RENAL STENT SYSTEM | 2011-07-20 |
| P070015 | PMA | XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS | 2008-07-02 |
Recalls
49 product recalls in 18 recall events; 13 initiated in the last five years. Most recent: 2024-11-06.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Abbott Vascular (a text match, not an official crosswalk):
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Abbott Laboratories (889 510(k)s)
- ABBOTT MEDICAL (60 510(k)s)
- Abbott Diabetes Care, Inc. (39 510(k)s)
- Abbott Diagnostics (28 510(k)s)
- Abbott Point of Care, Inc. (22 510(k)s)
- Abbott Molecular, Inc. (18 510(k)s)
- Abbott Mfg., Inc. (14 510(k)s)
- Abbott Medical Optics, Inc. (13 510(k)s)
- Abbott (13 510(k)s)
- Abbott Spine, Inc. (13 510(k)s)
- Abbott Ireland Diagnostics Division (8 510(k)s)
- Abbott Diagnostics Scarborough, Inc. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Abbott Vascular?
FDA lists 50 510(k) clearances under the applicant name “Abbott Vascular” (first 2000, latest 2022), plus 14 PMA decisions, across 19 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Abbott Vascular?
The median time from FDA receipt to decision across 510(k)s cleared under the name Abbott Vascular is 65 days. Since 2017: 38 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Abbott Vascular?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 19); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 8); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 7).
Next steps
- See all 50 Abbott Vascular clearances with predicates and recalls
- Run predicate analysis for product code DQX, Abbott Vascular's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.