GoBack Crossing Catheter
FDA 510(k) clearance K211802 · decided 2022-03-01
Clearance details
- K-number
- K211802
- Device name
- GoBack Crossing Catheter
- Applicant
- Upstream Peripheral Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-10
- Decision date
- 2022-03-01
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- PDU
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Caesarea, IL
- Third-party review
- No
- Expedited review
- No
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| Crosser iQ CTO Recanalization System (K203363) | C.R. Bard, Inc. | 2021-08-12 |
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Recalls involving this device
No recalls on record reference this clearance.