Recall Z-0116-2016— Concentric Medical Inc
Class II · Terminated
Class II FDA medical device recall by Concentric Medical Inc, initiated 2015-08-19, terminated 2015-10-09. It names one FDA 510(k) clearance: K133177. Product: Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.. Reason: One Distal Access Catheter intended for distribution in Korea, was found at a US location..
- Recalling firm
- Concentric Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-19
- Terminated
- 2015-10-09
- Firm location
- Mountain View, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
Reason for recall
One Distal Access Catheter intended for distribution in Korea, was found at a US location.
Data sourced from openFDA. This site is unofficial and independent of the FDA.