TERUMO AL8X ARTERIAL FILTER WITH X-COATING— 510(k) K032128
Substantially EquivalentTerumo Cardiovascular Systems Corp.
FDA 510(k) clearance K032128 for TERUMO AL8X ARTERIAL FILTER WITH X-COATING, Substantially Equivalent on 2003-08-01. 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.