FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
K Number: K895431
·
Decision Oct 13, 1989
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
4
Review Days
37
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Basic Information
- Device Name
- JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
- K Number
- K895431
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Patient Care, Inc.
- Date Received
- September 6, 1989
- Decision Date
- October 13, 1989
- Product Code
- KMK
- 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
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Other Clearances by Johnson & Johnson Patient Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892851 | ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER | Sep 26, 1989 | Substantially Equivalent for Some Indications |
| K890545 | NU-DERM HYDROCOLLOID DRESSING | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K884749 | JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE | Dec 15, 1988 | Substantially Equivalent |