FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CenterCross Ultra Catheter
K Number: K152456
·
Decision Jan 26, 2016
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
8
Review Days
151
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Basic Information
- Device Name
- CenterCross Ultra Catheter
- K Number
- K152456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roxwood Medical, Inc.
- Date Received
- August 28, 2015
- Decision Date
- January 26, 2016
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Roxwood Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170403 | CenterCross Ultra LV Catheter | Mar 7, 2017 | Substantially Equivalent |
| K160681 | CenterCross Ultra Catheter | Jun 17, 2016 | Substantially Equivalent |
| K152957 | MultiCross Catheter | Mar 4, 2016 | Substantially Equivalent |
| K151082 | MicroCross Catheter | Jun 7, 2015 | Substantially Equivalent |
| K143744 | MicroCross Catheter | Apr 14, 2015 | Substantially Equivalent |
| K140910 | CENTERCROSS CATHETER | Nov 19, 2014 | Substantially Equivalent |
| K121763 | MULTICROSS SUPPORT CATHETER | Nov 27, 2012 | Substantially Equivalent |