FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
K Number: K050803
·
Decision Jun 30, 2005
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
236
Applicant Total
7
Review Days
92
Basic Information
- Device Name
- PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES
- K Number
- K050803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- VITAID, LTD.
- Date Received
- March 30, 2005
- Decision Date
- June 30, 2005
- 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 |
Similar 510(k) Clearances
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Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
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ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)
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Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
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Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
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Other Clearances by VITAID, LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K932647 | WIRE REINFORCED ENDOTRACHEAL TUBE | Nov 2, 1993 | Substantially Equivalent |
| K901738 | SELFCATH | Jun 27, 1990 | Substantially Equivalent |
| K894883 | PHYCON ALL SILICONE BALLOON CATHETER | Apr 25, 1990 | Substantially Equivalent |
| K894794 | AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP | Nov 21, 1989 | Substantially Equivalent |
| K894669 | LASER SHIELDING TUBE | Oct 13, 1989 | Substantially Equivalent |
| K894337 | UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM | Sep 29, 1989 | Substantially Equivalent |