Advanced Cardiovascular Systems, Inc.: FDA clearances and approvals
Advanced Cardiovascular Systems, Inc. has 103 FDA 510(k) clearances (first 1982, latest 2002), plus 1 PMA decision, across 15 product codes in 4 review panels. Median 510(k) review time: 81 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 | 45 | 45 |
| DQY | Catheter, Percutaneous | 19 | 19 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 10 | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 6 |
| DXT | Injector And Syringe, Angiographic | 4 | 4 |
| DYB | Introducer, Catheter | 4 | 4 |
| MAV | Syringe, Balloon Inflation | 4 | 4 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| LYK | Angioscope | 2 | 2 |
Plus 5 more product codes.
Review panels
- Cardiovascular (96)
- General Hospital (4)
- Gastroenterology and Urology (2)
- Immunology (1)
Most recent Advanced Cardiovascular Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | DQX | 2002-01-24 | 171 |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | FGE | 2000-03-17 | 28 |
| K994229 | VERIPATH PERIPHERAL GUIDING CATHETER | DQY | 2000-02-25 | 71 |
| K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | DQX | 1999-10-28 | 122 |
| K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 | FGE | 1999-09-02 | 170 |
| K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | DQX | 1997-01-22 | 128 |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | MAV | 1996-09-12 | 78 |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | MAV | 1996-05-08 | 21 |
| K955175 | ACS ANCHOR EXCHANGE DEVICE | DQX | 1996-04-05 | 144 |
| K953987 | ACS TOURGIDE GUIDING CATHETER | DQY | 1995-12-07 | 106 |
93 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810046 | PMA | SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE | 1982-03-03 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Cardiovascular Systems, Inc..
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 Advanced Cardiovascular Systems, Inc.'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 Advanced Cardiovascular Systems, Inc. have?
Advanced Cardiovascular Systems, Inc. has 103 FDA 510(k) clearances (first 1982, latest 2002), plus 1 PMA decision, across 15 product codes in 4 review panels.
How long does FDA take to clear Advanced Cardiovascular Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Cardiovascular Systems, Inc.'s cleared 510(k)s is 81 days.
What devices does Advanced Cardiovascular Systems, Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 45); DQY (Catheter, Percutaneous, 19); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 10).
Has Advanced Cardiovascular Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Cardiovascular Systems, Inc. Related entities may recall under other names.
Next steps
- See all 103 Advanced Cardiovascular Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Advanced Cardiovascular Systems, Inc.'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.