FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
K Number: K131452
·
Decision Sep 5, 2013
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
5
Review Days
108
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300
- K Number
- K131452
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St. Jude Medical Systems AB
- Date Received
- May 20, 2013
- Decision Date
- September 5, 2013
- Product Code
- DXO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXO), ordered by most recent decision date.
OptoMonitor 3
FDA 510(k)
FDA Class 2
·Cardiovascular
OptoMonitor 3
FDA 510(k)
FDA Class 2
·Cardiovascular
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
FDA 510(k)
FDA Class 2
·Cardiovascular
TruWave Disposable Pressure Transducer
FDA 510(k)
FDA Class 2
·Cardiovascular
OptoMonitor 3
FDA 510(k)
FDA Class 2
·Cardiovascular
OptoMonitor 3
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by St. Jude Medical Systems AB
| K Number | Device Name | ||
|---|---|---|---|
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 | Nov 13, 2014 | Substantially Equivalent |
| K133587 | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 | Dec 20, 2013 | Substantially Equivalent |
| K111854 | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER | Oct 21, 2011 | Substantially Equivalent |
| K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F | Feb 24, 2011 | Substantially Equivalent |