FFRangio
FDA 510(k) clearance K192442 · decided 2019-12-09
Clearance details
- K-number
- K192442
- Device name
- FFRangio
- Applicant
- Cathworks, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-06
- Decision date
- 2019-12-09
- Days to decision
- 94 days
- Clearance type
- Special
- Product code
- QEK
- Device class
- 2
- Regulation number
- 870.1415
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kfar-Saba, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FFRangio System (K182149) | Cathworks, Ltd. | 2018-12-19 |
Recalls involving this device
No recalls on record reference this clearance.