TERUMO PALL AL3X ARTERIAL FILTER— 510(k) K083747
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K083747 for TERUMO PALL AL3X ARTERIAL FILTER, Substantially Equivalent on 2009-08-20. Applicant: Terumo Cardiovascular Systems Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corp.
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkton, MD, US
Recent devices under product code DTM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.