FDA.report

510(k) K896108

Device
THE PILOT SCIMED TORQUE DEVICE
Applicant
SCIMED LIFE SYSTEMS, INC.
510(k) number
K896108
Product code
LOX  
Decision
Substantially Equivalent (SESE)
Decision date
1990-01-09
Date received
1989-10-23
Regulation
870.5100
Classification name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
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

Contact
CARROLL KNOST
Address
6655 Wedgwood Rd. Maple Grove MN US 55369 55369

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
20193489078012NAMICMEDLINE INDUSTRIES, INC.2021-07-26
H74902470012NAMICNAVILYST MEDICAL, INC.2016-09-20

Legacy Summary

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FDA Review

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