MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
FDA 510(k) clearance K091504 · decided 2009-06-19
Clearance details
- K-number
- K091504
- Device name
- MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
- Applicant
- Micrus Endovascular Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-05-21
- Decision date
- 2009-06-19
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.