EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET— 510(k) K881279
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K881279 for EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET, Substantially Equivalent on 1988-05-18. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code DTI
- Device class
- Class 1
- Regulation
- 21 CFR 870.3945
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Recent devices under product code DTI
view allMore clearances from Baxter Healthcare Corp
view all- K190910 — PrisMax System Version 2
- K163530 — PrisMax Control Unit
- K130531 — ULTRAFUSE
- K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
- K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
Data sourced from openFDA. This site is unofficial and independent of the FDA.