FKA · Class II · 21 CFR 876.5540

FDA Product Code FKA: Dilator, Vessel

Leading manufacturers include Spire Biomedical, Inc., Akcess Medical Products, Inc. and Vas-Cath, Inc..

3
Total
3
Cleared
266d
Avg days
1991
Since

FDA 510(k) Cleared Dilator, Vessel Devices (Product Code FKA)

3 devices
1–3 of 3
Cleared Oct 11, 2002
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
K022620
Spire Biomedical, Inc.
Gastroenterology & Urology · 65d
Cleared Jul 01, 1993
VAS-CATH DUALATOR(TM) VESSEL DILATOR
K914210
Vas-Cath, Inc.
Gastroenterology & Urology · 651d
Cleared Apr 29, 1991
VESSEL DILATORS
K910502
Akcess Medical Products, Inc.
Gastroenterology & Urology · 83d

About Product Code FKA - Regulatory Context