ASTRA 2,3,4 AND 6: CHIP REVISION
FDA 510(k) clearance K863000 · decided 1986-08-19
Clearance details
- K-number
- K863000
- Device name
- ASTRA 2,3,4 AND 6: CHIP REVISION
- Applicant
- Cardiac Pacemakers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-08
- Decision date
- 1986-08-19
- Days to decision
- 11 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.