1
/
of
0
FDA 510(k), K191546, Epicardial Access System
FDA 510(k), K191546, Epicardial Access System
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
Unit price
/
per
510(K) Number: K191546
Device Name: Epicardial Access System
Manufacturer: May Tsai
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: KXA
Date Received: 06/12/2019
Decision Date: 08/02/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Epicardial Access System
Manufacturer: May Tsai
Device Classification Name: Introducer, Catheter
Regulation Number: DYB
Classification Product Code: KXA
Date Received: 06/12/2019
Decision Date: 08/02/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details