FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGYLE TARTAN I TRACHEAL TUBE
K Number: K821670
·
Decision Jun 24, 1982
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
191
Review Days
22
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Basic Information
- Device Name
- ARGYLE TARTAN I TRACHEAL TUBE
- K Number
- K821670
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sherwood Medical Co.
- Date Received
- June 2, 1982
- Decision Date
- June 24, 1982
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | Nov 25, 1998 | Substantially Equivalent |
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| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Aug 5, 1996 | Substantially Equivalent |
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| K960632 | KANGAROO FEEDING TUBE PLACMENT STYLET | May 9, 1996 | Substantially Equivalent |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Mar 28, 1996 | Substantially Equivalent |
| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
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| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |