PULSATILE ANTI-EMBOLISM SYS.PUMP— 510(k) K911853
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K911853 for PULSATILE ANTI-EMBOLISM SYS.PUMP, Substantially Equivalent on 1991-07-22. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
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