FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
FLEXICARE MEDICAL ENDOTRACHEAL TUBES
K Number: K091591
·
Decision Jun 17, 2009
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- FLEXICARE MEDICAL ENDOTRACHEAL TUBES
- K Number
- K091591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Flexicare Medical, Ltd.
- Date Received
- June 2, 2009
- Decision Date
- June 17, 2009
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K132619 | CLASSIC INTERMITTENT CATHETER | Oct 11, 2013 | Substantially Equivalent |
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