EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
FDA 510(k) clearance K891687 · decided 1989-05-31
Clearance details
- K-number
- K891687
- Device name
- EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
- Applicant
- Medtronic Blood Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-22
- Decision date
- 1989-05-31
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
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