FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
K Number: K083482
·
Decision Apr 2, 2009
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
129
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Basic Information
- Device Name
- COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
- K Number
- K083482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Vascular, Inc.
- Date Received
- November 24, 2008
- Decision Date
- April 2, 2009
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Cook Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | Nov 12, 2014 | Substantially Equivalent |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | Jul 1, 2014 | Substantially Equivalent |
| K110347 | DOPPLER MONITOR | Mar 16, 2011 | Substantially Equivalent |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | Sep 30, 2008 | Substantially Equivalent |
| K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 | May 10, 2006 | Substantially Equivalent |
| K032223 | COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH | Oct 15, 2003 | Substantially Equivalent |
| K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM | May 27, 2003 | Substantially Equivalent |
| K022649 | COOK-SWARTZ DOPPLER FLOW PROBE | Sep 6, 2002 | Substantially Equivalent |
| K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | Apr 25, 2002 | Substantially Equivalent |
| K002958 | SHAPEABLE DOPPLER FLOW PROBE | Dec 18, 2001 | Substantially Equivalent |