Empira Rx Ptca Dilatation Catheter, Empria Nc Rx Ptca Dilatation Catheter

510(k) K110133

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK110133	Date10 Jun 2011Cleared	StatusActive

3 recalls · FDA

2 recalls, same reason
- Terminated Z-2556-2014 FDA Class II initiated 23 Jun 2014
- Terminated Z-2557-2014 FDA Class II initiated 23 Jun 2014
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
- Terminated Z-1784-2014 FDA Class II initiated 5 Feb 2013
Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

1 jurisdiction

United States — FDA 510(k) Active

510(k)