FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
K Number: K041348
·
Decision Jul 13, 2004
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
3
Review Days
54
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Basic Information
- Device Name
- PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
- K Number
- K041348
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smiths Medical
- Date Received
- May 20, 2004
- Decision Date
- July 13, 2004
- Product Code
- JOH
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
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