FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
GoBack Crossing Catheter
K Number: K211802
·
Decision Mar 1, 2022
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
2
Review Days
264
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Basic Information
- Device Name
- GoBack Crossing Catheter
- K Number
- K211802
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Upstream Peripheral Technologies, Ltd.
- Date Received
- June 10, 2021
- Decision Date
- March 1, 2022
- Product Code
- PDU
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by Upstream Peripheral Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K182937 | Upstream GoBack Crossing Catheter | May 23, 2019 | Substantially Equivalent |