CATHETER, TWO STAGE VENOUS RETURN
FDA 510(k) clearance K770431 · decided 1977-03-16
Clearance details
- K-number
- K770431
- Device name
- CATHETER, TWO STAGE VENOUS RETURN
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1977-03-07
- Decision date
- 1977-03-16
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- 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
| Record | Firm | Date |
|---|---|---|
| Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connecto recall (Z-2100-2014) | Terumo Cardiovascular Systems Corporation | 2014-07-23 |