FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PICC INSERTION TRAY
K Number: K931668
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
212
Registration Numbers
213
Same Product Code
496
Applicant Total
16
Review Days
335
Basic Information
- Device Name
- PICC INSERTION TRAY
- K Number
- K931668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- CLINIPAD CORP.
- Date Received
- April 6, 1993
- Decision Date
- March 7, 1994
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by CLINIPAD CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K931560 | CARDIAC CATHETERIZATION TRAY | Jul 11, 1994 | Unknown |
| K932071 | I.V. START KIT | Feb 17, 1994 | Unknown |
| K932010 | V.A.D. ACCESS KIT | Feb 3, 1994 | Substantially Equivalent |
| K932036 | LACERATION TRAY | Dec 13, 1993 | Unknown |
| K932016 | TRACHEOSTOMY CARE TRAY | Nov 3, 1993 | Substantially Equivalent |
| K862562 | PUNCH BIOPSY KIT | Oct 7, 1986 | Substantially Equivalent |
| K862563 | TRACHEOSTOMY CLEANSING SOLUTION | Jul 15, 1986 | Substantially Equivalent |
| K833075 | WET DRESSING KIT | Jan 27, 1984 | Substantially Equivalent |
| K833432 | CATHETER INSERTION KIT | Dec 28, 1983 | Substantially Equivalent |
| K830476 | OR PREP KIT | Mar 31, 1983 | Substantially Equivalent |