Medical device manufacturer
Advanced Cardiovascular Systems, Inc.
Advanced Cardiovascular Systems, Inc. holds 103 FDA 510(k) clearances across 14 product codes. Median elapsed review time is 81 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 103
- Product codes
- 14
- Median review
- 81 days
- Recall records
- 0
How does FDA spell Advanced Cardiovascular Systems, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Advanced Cardiovascular Systems, Inc. file in?
14 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | 45 | 83 days | |
| DQY | Catheter, Percutaneous | 19 | 73 days | |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 10 | 42 days | |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 41 days | |
| DXT | Injector And Syringe, Angiographic | 4 | 41 days | |
| DYB | Introducer, Catheter | 4 | 72 days | |
| MAV | Syringe, Balloon Inflation | 4 | 78 days | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 28 days | |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 2 | 34 days | |
| LYK | Angioscope | 2 | 72 days | |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 | 47 days | |
| DQT | Occluder, Catheter Tip | 1 | 130 days | |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 42 days | |
| KRA | Catheter, Continuous Flush | 1 | 580 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Advanced Cardiovascular Systems, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Advanced Cardiovascular Systems, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K012534 | HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING | DQX | 171 | |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | FGE | 28 | |
| K994229 | VERIPATH PERIPHERAL GUIDING CATHETER | DQY | 71 | |
| K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | DQX | 122 | |
| K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 | FGE | 170 | |
| K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | DQX | 128 | |
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) | MAV | 78 | |
| K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | MAV | 21 | |
| K955175 | ACS ANCHOR EXCHANGE DEVICE | DQX | 144 | |
| K953987 | ACS TOURGIDE GUIDING CATHETER | DQY | 106 |
Source: openFDA device/510k · retrieved
Watch what Advanced Cardiovascular Systems, Inc. files next
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