FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K Number: K950201
·
Decision Dec 15, 1995
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
191
Review Days
331
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Basic Information
- Device Name
- ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
- K Number
- K950201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sherwood Medical Co.
- Date Received
- January 18, 1995
- Decision Date
- December 15, 1995
- Product Code
- JOL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | FDA class 2 | General Hospital |
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HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
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Other Clearances by Sherwood Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K981365 | MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS | Nov 25, 1998 | Substantially Equivalent |
| K960982 | MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA | Dec 23, 1996 | Substantially Equivalent |
| K962880 | SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM | Dec 9, 1996 | Unknown |
| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Aug 5, 1996 | Substantially Equivalent |
| K960677 | KANGAROO JEJUNAL FEEDING SYSTEM | May 13, 1996 | Substantially Equivalent |
| 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 |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K954300 | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY | Dec 13, 1995 | Substantially Equivalent |