FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
K Number: K063114
·
Decision Feb 9, 2007
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
63
Applicant Total
14
Review Days
121
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Basic Information
- Device Name
- DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
- K Number
- K063114
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coeur, Inc.
- Date Received
- October 11, 2006
- Decision Date
- February 9, 2007
- Product Code
- FPK
- 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 |
|---|---|---|---|
| FPK | Tubing, Fluid Delivery | FDA class 2 | General Hospital |
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Other Clearances by Coeur, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip | Aug 18, 2017 | Substantially Equivalent |
| K161471 | MR Syringe Dual Pack for Solaris Injectors | Oct 6, 2016 | Substantially Equivalent |
| K150902 | 330psi Extension Y-Line with Dual Check Valve | Oct 22, 2015 | Substantially Equivalent |
| K142745 | 125mL CT Syringe | Apr 1, 2015 | Substantially Equivalent |
| K140469 | MR SYRINGE DUAL PACK | Jul 28, 2014 | Substantially Equivalent |
| K133600 | COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR | Apr 30, 2014 | Substantially Equivalent |
| K120892 | DISPOSABLE 330PSI EXTENSION LINES | Jun 10, 2013 | Substantially Equivalent |
| K113498 | DISPOSABLE TORQUE DEVICE | Jul 20, 2012 | Substantially Equivalent |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | Jan 20, 2012 | Substantially Equivalent |
| K090487 | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 | Oct 19, 2009 | Substantially Equivalent |