FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K Number: K971267
·
Decision Sep 25, 1997
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
43
Review Days
174
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Basic Information
- Device Name
- SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
- K Number
- K971267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mallinckrodt Medical
- Date Received
- April 4, 1997
- Decision Date
- September 25, 1997
- 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 |
Similar 510(k) Clearances
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Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
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Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
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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 |
| K963732 | PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA | Jun 26, 1997 | Substantially Equivalent |
| K955721 | CUFFED OROPHARYNGEAL AIRWAY (COPA) | Mar 28, 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 |