FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
K Number: K162729
·
Decision Aug 11, 2017
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
175
Review Days
316
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Basic Information
- Device Name
- Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K Number
- K162729
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5790
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Incorporated
- Date Received
- September 29, 2016
- Decision Date
- August 11, 2017
- Product Code
- BSR
- 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 |
|---|---|---|---|
| BSR | Stylet, Tracheal Tube | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSR), ordered by most recent decision date.
TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
FDA 510(k)
FDA Class 1
·Anesthesiology
TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
FDA 510(k)
FDA Class 1
·Anesthesiology
MOLLOY INTUBATING STYLETTE
FDA 510(k)
FDA Class 1
·Anesthesiology
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
FDA 510(k)
FDA Class 1
·Anesthesiology
LIGHTED FLEXGUIDE (MODIFICATION)
FDA 510(k)
FDA Class 1
·Anesthesiology
RUSCH ENDOTRACHEAL TUBE STYLET
FDA 510(k)
FDA Class 1
·Anesthesiology
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