Company ยท US
Spectramed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 1990. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KXO | Monitor, Pressure, Intrauterine | 4 |
| DQF | Actuator, Syringe, Injector Type | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DYB | Introducer, Catheter | 1 |
| KRB | Probe, Thermodilution | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 1990 | K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED Spectramed, Inc. | KXO |
| Nov 6, 1989 | K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 Spectramed, Inc. | KRB |
| Oct 24, 1989 | K895323 | MODEL DT-BAL, BALANCE SAVER Spectramed, Inc. | KXO |
| Aug 15, 1989 | K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP Spectramed, Inc. | KXO |
| Feb 1, 1989 | K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. Spectramed, Inc. | KXO |
| Jan 25, 1989 | K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. Spectramed, Inc. | DSK |
| Sep 28, 1988 | K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH Spectramed, Inc. | DYB |
| May 25, 1988 | K875337 | HEPARIN COATED LUMINAL PACING CATHETER Spectramed, Inc. | DQO |
| Mar 22, 1988 | K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE Spectramed, Inc. | DQF |
| Jan 12, 1988 | K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS Spectramed, Inc. | DRS |
| Sep 16, 1987 | K871573 | CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITS Spectramed, Inc. | DQY |
| Apr 20, 1987 | K865101 | SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM Spectramed, Inc. | DXG |
| Mar 6, 1987 | K864507 | V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 Spectramed, Inc. | LDF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||