SWAN-GANZ FLOW-DIRECTED THERMODILUTION
FDA 510(k) clearance K810352 · decided 1981-03-27
Clearance details
- K-number
- K810352
- Device name
- SWAN-GANZ FLOW-DIRECTED THERMODILUTION
- Applicant
- American Edwards Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1981-02-10
- Decision date
- 1981-03-27
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- DYG
- Device class
- 2
- Regulation number
- 870.1240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GARREN GASTRIC BUBBLE (P840025/S011) | American Edwards Laboratories | 1987-03-17 |
| GARREN GASTRIC BUBBLE (P840025/S008) | American Edwards Laboratories | 1986-10-16 |
| GARREN GASTRIC BUBBLE (P840025/S006) | American Edwards Laboratories | 1986-07-25 |
| GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005) | American Edwards Laboratories | 1986-05-12 |
| GARREN GASTRIC BUBBLE (P840025/S003) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S002) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S004) | American Edwards Laboratories | 1986-01-23 |
| GARREN GASTRIC BUBBLE (P840025/S001) | American Edwards Laboratories | 1985-12-18 |