FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
K Number: K112562
·
Decision Dec 15, 2011
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
0
Applicant Total
5
Review Days
80
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Basic Information
- Device Name
- BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER
- K Number
- K112562
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kimberly-Clark
- Date Received
- September 26, 2011
- Decision Date
- December 15, 2011
- Product Code
- OYI
- 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 |
|---|---|---|---|
| OYI | Non-Bronchoscopic Bronchoalveolar Lavage Catheter | FDA class 1 | Anesthesiology |
Other Clearances by Kimberly-Clark
| K Number | Device Name | ||
|---|---|---|---|
| K113340 | KIMBERLY-CLARK CHILD'S FACEMASK | May 4, 2012 | Substantially Equivalent |
| K111402 | KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL | Oct 20, 2011 | Substantially Equivalent |
| K103150 | KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK | Sep 23, 2011 | Substantially Equivalent |
| K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | Jul 21, 2010 | Substantially Equivalent |