Stanco Medical, Inc.
Mchenry, IL, US
Stanco Medical, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Stanco Medical, Inc. between 1979 and 1981. The busiest year on record is 1980, with 12. The most recent is 1981, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 5 |
| 1980 | 12 |
| 1981 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K810643 | UNIVERSAL PACING ELECTRODE KIT | LDF | Substantially Equivalent | |
| K810642 | ATRIAL-VENTRICULAR PACING ELECTRODE KIT | LDF | Substantially Equivalent | |
| K802289 | PERICARDIOCENTESIS KIT | DOR | Substantially Equivalent | |
| K802288 | SWAN GANZ CATHETER PLACEMENT KIT | DYG | Substantially Equivalent | |
| K802287 | RIGHT ATRIAL LINE KIT | DQY | Substantially Equivalent | |
| K802259 | TRANSVENOUS PACEMAKER ELECTRODE KIT | LDF | Substantially Equivalent | |
| K802290 | REGIONAL INTRAVENOUS ANESTHESIA KIT | CAZ | Substantially Equivalent | |
| K802328 | DISP. TOUGY-BORST TYPE ADAPTOR W/PORT | DTZ | Substantially Equivalent | |
| K802327 | SHEATH DILATOR SET | DRE | Substantially Equivalent | |
| K802326 | PRESSURE MONITORING LINES | DRI | Substantially Equivalent | |
| K802260 | VASCULAR CATHETER WIREGUIDES | DQX | Substantially Equivalent | |
| K802329 | DISPOSABLE CONSTRAST DELIVERY SPIKE KIT | FPA | Substantially Equivalent | |
| K802261 | PRESSURE GAUGE ACCESSORY KIT/DILATATION | DWF | Substantially Equivalent | |
| K802258 | STOPCOCK 2-WAY, 3-WAY & 4-WAY | FMG | Substantially Equivalent | |
| K792172 | PERCUTANEOUS SHEATH INTRO. KIT OR TRAY | DYB | Substantially Equivalent | |
| K792171 | COMPLETE TRAY CENTRAL VENOUS PRESSURE | DYB | Substantially Equivalent | |
| K792170 | PERCUTANEOUS SHEATH (MULTI-CATH)SIDE | DYB | Substantially Equivalent | |
| K792131 | TEMPORARY TRANSVENOUS PACMKER. ELECTRODE | DYB | Substantially Equivalent | |
| K792130 | TRANSVENOUS BALLOON CATH. INTRO. KIT | DYB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CAZAnesthesia Conduction Kit
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DYGCatheter, Flow Directed
- DQYCatheter, Percutaneous
- DREDilator, Vessel, For Percutaneous Catheterization
- LDFElectrode, Pacemaker, Temporary
- DYBIntroducer, Catheter
- DRIMonitor, Line Isolation
- DTZOxygenator, Cardiopulmonary Bypass
- DORRadioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.
- FPASet, Administration, Intravascular
- FMGStopcock, I.V. Set
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain