PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300— 510(k) K131452
Substantially EquivalentSt. Jude Medical Systems AB
FDA 510(k) clearance K131452 for PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300, Substantially Equivalent on 2013-09-05. Applicant: St. Jude Medical Systems AB. Device class: 2.
Clearance details
- Applicant
- St. Jude Medical Systems AB
- Product code
- Code DXO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2870
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westford, MA, US
Recent devices under product code DXO
view allMore clearances from St. Jude Medical Systems AB
view all- K140466 — PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300
- K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300
- K111854 — AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
- K110193 — FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER
Adverse events under product code DXO
product code DXO- Death
- 10
- Injury
- 156
- Malfunction
- 884
- Total
- 1,050
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.