FDA.report

510(k) K203655

Device
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
Applicant
Innovative Health, LLC
510(k) number
K203655
Product code
NLH
Decision
Substantially Equivalent (SESE)
Decision date
2021-05-04
Date received
2020-12-15
Regulation
870.1220
Classification name
Catheter, Recording, Electrode, Reprocessed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Rick Ferreira
Address
1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257

FDA Registration Numbers

Source Documents

510(k) summary PDF

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