Recall Z-1302-2022— Volcano Corp
Class III · Ongoing
Class III FDA medical device recall by Volcano Corp, initiated 2022-05-13. It names one FDA 510(k) clearance: K153094. Product: Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797. Reason: Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications.
- Recalling firm
- Volcano Corp
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-05-13
- Firm location
- San Diego, 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
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
Reason for recall
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Data sourced from openFDA. This site is unofficial and independent of the FDA.