INTRACARDIA SUCKERS
FDA 510(k) clearance K831759 · decided 1983-08-12
Clearance details
- K-number
- K831759
- Device name
- INTRACARDIA SUCKERS
- Applicant
- Research Industries Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-01
- Decision date
- 1983-08-12
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for h recall (Z-1749-2013) | Edwards Lifesciences, LLC | 2013-07-17 |
| Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product recall (Z-1967-2012) | Edwards Lifesciences, LLC | 2012-07-09 |