FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EUROMEDICAL POLY TRACHEOTOMY TUBE
K Number: K945874
·
Decision Dec 27, 1994
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
21
Review Days
26
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Basic Information
- Device Name
- EUROMEDICAL POLY TRACHEOTOMY TUBE
- K Number
- K945874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Regulatory & Marketing Services, Inc.
- Date Received
- December 1, 1994
- Decision Date
- December 27, 1994
- 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
Other 510(k) clearances with the same product code (JOH), ordered by most recent decision date.
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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Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
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TRACOE vario
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Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
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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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Shiley Neonatal/Pediatric Tracheostomy Tube
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Other Clearances by Regulatory & Marketing Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | Apr 10, 1996 | Substantially Equivalent |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | Oct 30, 1995 | Substantially Equivalent |
| K941342 | PAIN DOC | Oct 13, 1995 | Substantially Equivalent |
| K941543 | DIAL MEDICAL KIT | Feb 16, 1995 | Unknown |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Feb 15, 1995 | Substantially Equivalent |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K944383 | ORION RED URETHRAL CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944377 | ORION'S URINARY DRAINAGE SET | Dec 6, 1994 | Substantially Equivalent |