MICRO TRANSDUCER CATHETERS

Dilator, Vessel, For Percutaneous Catheterization

HONEYWELL, INC.

The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Micro Transducer Catheters.

Pre-market Notification Details

Device IDK813125
510k NumberK813125
Device Name:MICRO TRANSDUCER CATHETERS
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-04
Decision Date1981-12-14

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