FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Crosstella RX Balloon Dilatation Catheter
K Number: K152873
·
Decision Jan 22, 2016
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
10
Review Days
114
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Crosstella RX Balloon Dilatation Catheter
- K Number
- K152873
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIT), ordered by most recent decision date.
WAVE PTA Balloon Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Armada 14 NC PTA Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amethyst HP PTA OTW 0.035 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K152887 | Crosperio RX PTA 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 |