Company ยท US
Sterile Design, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1994. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQX | Wire, Guide, Catheter | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 1 |
| FMC | Patient Examination Glove | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FRG | Wrap, Sterilization | 1 |
| JOD | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | 1 |
| LRO | General Surgery Tray | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 1994 | K934688 | STERILE DESIGN Sterile Design, Inc. | LRO |
| Nov 8, 1985 | K841960 | CARDIO METRICS INVASIVE PRESSURE MONIT Sterile Design, Inc. | DRS |
| Mar 21, 1985 | K842356 | CUSTOM STERILE PROCEDURE KITS Sterile Design, Inc. | |
| Oct 19, 1984 | K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING Sterile Design, Inc. | DWE |
| Oct 15, 1984 | K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT Sterile Design, Inc. | FPA |
| Oct 15, 1984 | K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR Sterile Design, Inc. | JOD |
| Apr 25, 1984 | K834239 | SDI C-FLEX STERILE LIGHT HANDLE Sterile Design, Inc. | |
| Feb 4, 1984 | K834237 | GRADUATED GUIDE WIRE BOWL 8 Sterile Design, Inc. | DQX |
| Dec 31, 1981 | K813437 | PAN SET Sterile Design, Inc. | FRG |
| Oct 2, 1979 | K791738 | CUSTOM DRESSING CHANGE TRAYS Sterile Design, Inc. | FMC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||