FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CATHETER INSERTION TRAY
K Number: K922179
·
Decision Jul 2, 1993
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
11
Review Days
420
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Basic Information
- Device Name
- CATHETER INSERTION TRAY
- K Number
- K922179
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Medcare Custom Packaging, Inc.
- Date Received
- May 8, 1992
- Decision Date
- July 2, 1993
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Medcare Custom Packaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Jan 19, 1996 | Substantially Equivalent |
| K954442 | STERILE ISOTONIC SALINE & STERILE WATER | Dec 21, 1995 | Substantially Equivalent |
| K952759 | TOWEL PACK | Sep 29, 1995 | Substantially Equivalent |
| K950390 | URETHRAL CATHETERIZATION TRAY | May 30, 1995 | Substantially Equivalent |
| K943661 | STERILE PHYSIOLOGICAL SALINE/STERILE WATER | Apr 10, 1995 | Substantially Equivalent |
| K951149 | SINGLE USE INSTRUMENT TRAY | Apr 6, 1995 | Unknown |
| K934732 | PELVIC EXAM TRAY | Dec 30, 1994 | Substantially Equivalent |
| K942000 | BURN DRESSING TRAY | May 20, 1994 | Unknown |
| K936261 | CATHETER INSERTION TRAY | Mar 10, 1994 | Unknown |
| K901856 | CUSTOM WOUND MANAGEMENT KITS AND TRAYS | Aug 1, 1990 | Unknown |