FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
FDA 510(k) clearance K111284 · decided 2011-08-17
Clearance details
- K-number
- K111284
- Device name
- FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
- Applicant
- Ostial Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-05-06
- Decision date
- 2011-08-17
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|
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| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
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| Firefighter™ NC Pro PTCA Balloon Catheter (K223189) | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 |
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Recalls involving this device
No recalls on record reference this clearance.