EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER— 510(k) K110133
Substantially EquivalentCreganna-Tactx Medical
FDA 510(k) clearance K110133 for EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER, Substantially Equivalent on 2011-06-10. Applicant: Creganna-Tactx Medical. Device class: 2.
Clearance details
- Applicant
- Creganna-Tactx Medical
- Product code
- Code LOX
- Device class
- Class 2
- Regulation
- 21 CFR 870.5100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
Recent devices under product code LOX
view allMore clearances from Creganna-Tactx Medical
view allAdverse events under product code LOX
product code LOX- Death
- 190
- Injury
- 1,498
- Malfunction
- 9,670
- Total
- 11,358
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110133
K-number listed on FDA's recall record- Z-2556-2014 — Cordis EMPIRA NC RX PTCA Dilatation Catheter
- Z-2557-2014 — Cordis EMPIRA RX PTCA Dilatation Catheter
- Z-1784-2014 — Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110133.
Data sourced from openFDA. This site is unofficial and independent of the FDA.