Spectramed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDJanuary 19, 1990
K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267November 6, 1989
K895323MODEL DT-BAL, BALANCE SAVEROctober 24, 1989
K894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPAugust 15, 1989
K881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.February 1, 1989
K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.January 25, 1989
K881825MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATHSeptember 28, 1988
K875337HEPARIN COATED LUMINAL PACING CATHETERMay 25, 1988
K880740MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGEMarch 22, 1988
K873168SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESSJanuary 12, 1988
K871573CENTRAL VENOUS MULTI-LUMEN CATHETERS AND KITSSeptember 16, 1987
K865101SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEMApril 20, 1987
K864507V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540March 6, 1987