FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NEXTSTEP RETROGRADE
K Number: K130192
·
Decision May 10, 2013
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
19
Review Days
105
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Basic Information
- Device Name
- NEXTSTEP RETROGRADE
- K Number
- K130192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Arrow International, Inc.
- Date Received
- January 25, 2013
- Decision Date
- May 10, 2013
- Product Code
- MSD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Arrow International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP | May 27, 2020 | Substantially Equivalent |
| K200634 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit | Apr 9, 2020 | Substantially Equivalent |
| K190101 | UltraFlex IAB | Jun 28, 2019 | Substantially Equivalent |
| K190117 | Fiberoptix IAB | Jun 13, 2019 | Substantially Equivalent |
| K162820 | AC3 Series IABP System | Mar 31, 2017 | Substantially Equivalent |
| K141051 | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU | Jul 7, 2014 | Substantially Equivalent |
| K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET | Apr 26, 2013 | Substantially Equivalent |
| K122690 | ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE | Dec 21, 2012 | Substantially Equivalent |
| K122027 | ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER | Aug 28, 2012 | Substantially Equivalent |
| K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS | Jun 21, 2012 | Substantially Equivalent |