FDA 510(k), K151638, Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
FDA 510(k), K151638, Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
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510(K) Number: K151638
Device Name: Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
Manufacturer: Cathera, Inc.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 06/17/2015
Decision Date: 11/13/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter
Manufacturer: Cathera, Inc.
Device Classification Name: catheter, percutaneous
Regulation Number: 870.1250
Classification Product Code: DQY
Date Received: 06/17/2015
Decision Date: 11/13/2015
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.
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