FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRACHEOSTOMY CLEANSING SOLUTION
K Number: K862563
·
Decision Jul 15, 1986
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
1
Applicant Total
16
Review Days
12
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Basic Information
- Device Name
- TRACHEOSTOMY CLEANSING SOLUTION
- K Number
- K862563
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5795
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Clinipad Corp.
- Date Received
- July 3, 1986
- Decision Date
- July 15, 1986
- Product Code
- EPE
- 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 |
|---|---|---|---|
| EPE | Brush, Cleaning, Tracheal Tube | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPE), ordered by most recent decision date.
View allOther Clearances by Clinipad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K931560 | CARDIAC CATHETERIZATION TRAY | Jul 11, 1994 | Unknown |
| K931668 | PICC INSERTION TRAY | Mar 7, 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 |
| 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 |