FDA.report

510(k) K822806

Device
BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
Applicant
NOVA MEDICAL SPECIALTIES
510(k) number
K822806
Product code
DYG  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-01
Date received
1982-09-17
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
4221 Richmond Rd., NW Walker MI US 49534 49534

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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