FDA 510(k), K133265, QUADROX-IR ADULT AND SMALL ADULT
FDA 510(k), K133265, QUADROX-IR ADULT AND SMALL ADULT
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K133265
Device Name: QUADROX-IR ADULT AND SMALL ADULT
Manufacturer: WHITNEY TORNING
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: 10/23/2013
Date Received: 11/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: QUADROX-IR ADULT AND SMALL ADULT
Manufacturer: WHITNEY TORNING
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: 10/23/2013
Date Received: 11/12/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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