FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Crosperio RX PTA Balloon Dilatation Catheter
K Number: K152887
·
Decision Jan 22, 2016
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
10
Review Days
114
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Basic Information
- Device Name
- Crosperio RX PTA Balloon Dilatation Catheter
- K Number
- K152887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KANEKA Corporation
- Date Received
- September 30, 2015
- Decision Date
- January 22, 2016
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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Other Clearances by KANEKA Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | Mar 19, 2018 | Substantially Equivalent |
| K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | Jul 7, 2017 | Substantially Equivalent |
| K163372 | RX Takeru Balloon Dilatation Catheter | Apr 7, 2017 | Substantially Equivalent |
| K163479 | R2P Metacross RX | Jan 11, 2017 | Substantially Equivalent |
| K160004 | Crosstella OTW | Apr 29, 2016 | Substantially Equivalent |
| K160013 | Crosperio OTW | Apr 29, 2016 | Substantially Equivalent |
| K152873 | Crosstella RX Balloon Dilatation Catheter | Jan 22, 2016 | Substantially Equivalent |
| K152080 | Metacross OTW PTA Balloon Dilatation Catheter | Sep 24, 2015 | Substantially Equivalent |
| K150865 | Metacross RX PTA Balloon Dilitation Catheter | Aug 3, 2015 | Substantially Equivalent |