FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UltraFlex IAB
K Number: K190101
·
Decision Jun 28, 2019
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
161
Applicant Total
19
Review Days
157
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Basic Information
- Device Name
- UltraFlex IAB
- K Number
- K190101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3535
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrow International, Inc.
- Date Received
- January 22, 2019
- Decision Date
- June 28, 2019
- Product Code
- DSP
- 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K130192 | NEXTSTEP RETROGRADE | May 10, 2013 | Unknown |
| 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 |