SWAN GANZ

Catheter, Flow Directed

CLINCAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Swan Ganz.

Pre-market Notification Details

Device IDK771043
510k NumberK771043
Device Name:SWAN GANZ
ClassificationCatheter, Flow Directed
Applicant CLINCAL INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDYG  
CFR Regulation Number870.1240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-06-09
Decision Date1977-12-20

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