FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
K Number: K080339
·
Decision Oct 27, 2008
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
9
Review Days
262
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Basic Information
- Device Name
- MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
- K Number
- K080339
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medsource International, LLC
- Date Received
- February 8, 2008
- Decision Date
- October 27, 2008
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K150333 | MedSource Sharps Dart | May 8, 2015 | Substantially Equivalent |
| K140442 | MEDSOURCE SELECTABLE IV SET | Apr 22, 2014 | Substantially Equivalent |
| K140402 | MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET | Apr 3, 2014 | Substantially Equivalent |
| K131555 | MEDSOURCE IV SAFETY CATHETER | Jan 31, 2014 | Substantially Equivalent |
| K120424 | MEDSOURCE IV ADMINSTRATION SET | Jul 11, 2012 | Substantially Equivalent |
| K081516 | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT | Aug 26, 2008 | Substantially Equivalent |