FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOK-SWARTZ DOPPLER FLOW PROBE
K Number: K022649
·
Decision Sep 6, 2002
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- COOK-SWARTZ DOPPLER FLOW PROBE
- K Number
- K022649
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Vascular, Inc.
- Date Received
- August 9, 2002
- Decision Date
- September 6, 2002
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Cook Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K083482 | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET | Apr 2, 2009 | 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 |
| K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | Apr 25, 2002 | Substantially Equivalent |
| K002958 | SHAPEABLE DOPPLER FLOW PROBE | Dec 18, 2001 | Substantially Equivalent |