RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
FDA 510(k) clearance K892377 · decided 1989-12-07
Clearance details
- K-number
- K892377
- Device name
- RMI AORTIC ROOT/CORONARY SINUS MONIT./INFUSION SET
- Applicant
- Research Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-06
- Decision date
- 1989-12-07
- Days to decision
- 245 days
- Clearance type
- Traditional
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwa recall (Z-0542-2011) | Edwards Lifesciences Llc | 2010-12-07 |
| Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwar recall (Z-0543-2011) | Edwards Lifesciences Llc | 2010-12-07 |