FDA.report

510(k) K841639

Device
NOVA BALLOON THERMODILUTION CATH.
Applicant
NOVA MEDICAL SPECIALTIES
510(k) number
K841639
Product code
DYG  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-12
Date received
1984-04-20
Regulation
870.1240
Classification name
Catheter, Flow Directed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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