FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
K Number: K113277
·
Decision Jun 21, 2012
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
297
Applicant Total
15
Review Days
227
Basic Information
- Device Name
- ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
- K Number
- K113277
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ARROW INTERNATIONAL, INC.
- Date Received
- November 7, 2011
- Decision Date
- June 21, 2012
- Product Code
- LJS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by ARROW INTERNATIONAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K162820 | AC3 Series IABP System | Mar 31, 2017 | Substantially Equivalent |
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| 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 |
| K080604 | PRESSURE INJFECTABLE PICC | Jun 27, 2008 | Substantially Equivalent |
| K073451 | PRESSURE INJECTABLE PICC | Jan 15, 2008 | Substantially Equivalent |
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER | Aug 30, 2007 | Substantially Equivalent |
| K061289 | ARROW PRESSURE INJECTABLE PICC | Aug 24, 2006 | Substantially Equivalent |