S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM

Port & Catheter, Implanted, Subcutaneous, Intravascular

HARBOR MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Harbor Medical Devices, Inc. with the FDA for S.e.a.-port(tm) Vascular Access System.

Pre-market Notification Details

Device IDK882190
510k NumberK882190
Device Name:S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant HARBOR MEDICAL DEVICES, INC. 25 DRYDOCK AVE. Boston,  MA  02210 -3912
ContactJoshua Tolkoff
CorrespondentJoshua Tolkoff
HARBOR MEDICAL DEVICES, INC. 25 DRYDOCK AVE. Boston,  MA  02210 -3912
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-24
Decision Date1988-06-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.