FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K Number: K955721
·
Decision Mar 28, 1997
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
43
Review Days
466
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Basic Information
- Device Name
- CUFFED OROPHARYNGEAL AIRWAY (COPA)
- K Number
- K955721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mallinckrodt Medical
- Date Received
- December 18, 1995
- Decision Date
- March 28, 1997
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAE), ordered by most recent decision date.
LMA FAMILY OF AIRWAYS
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KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
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KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
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KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
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FDA Class 1
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RUSCH OPTOSAFE
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KEISEI
FDA 510(k)
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Other Clearances by Mallinckrodt Medical
| K Number | Device Name | ||
|---|---|---|---|
| K082520 | SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES | Oct 2, 2008 | Substantially Equivalent |
| K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | Jun 16, 2005 | Substantially Equivalent |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Dec 29, 1997 | Substantially Equivalent |
| K971267 | SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF | Sep 25, 1997 | Substantially Equivalent |
| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | Jun 26, 1997 | Substantially Equivalent |
| K965132 | HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES | Mar 20, 1997 | Substantially Equivalent |
| K962045 | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT | Nov 26, 1996 | Substantially Equivalent |
| K962173 | SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES | Oct 4, 1996 | Substantially Equivalent |
| K955680 | SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED | Mar 13, 1996 | Substantially Equivalent |
| K954749 | MALLINCKRODT SHILEY 15MM CAP | Jan 24, 1996 | Substantially Equivalent |