RECRUIT MICROCATHETER
FDA 510(k) clearance K091563 · decided 2009-07-30
Clearance details
- K-number
- K091563
- Device name
- RECRUIT MICROCATHETER
- Applicant
- Reverse Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-05-28
- Decision date
- 2009-07-30
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- MMX
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.