FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
K Number: K896046
·
Decision Jan 11, 1990
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
13
Review Days
86
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Basic Information
- Device Name
- VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
- K Number
- K896046
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Vitaphore Corp.
- Date Received
- October 17, 1989
- Decision Date
- January 11, 1990
- 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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Other Clearances by Vitaphore Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914579 | SILVER FOAM WOUND DRESSING | Feb 21, 1992 | Substantially Equivalent |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Oct 15, 1991 | Substantially Equivalent |
| K895920 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS | Jun 6, 1991 | Substantially Equivalent |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Aug 17, 1990 | Substantially Equivalent |
| K891993 | COLLAGEN NEUROSPONGE | Mar 23, 1990 | Substantially Equivalent |
| K896455 | VITACHOICE WOUND DRESSING | Feb 15, 1990 | Substantially Equivalent |
| K895993 | VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE | Jan 11, 1990 | Substantially Equivalent |
| K890435 | VITAACCESS CATHETER INTRODUCER KIT | Mar 29, 1989 | Unknown |
| K882100 | VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT | Jul 13, 1988 | Substantially Equivalent |
| K872998 | VITAACCESS (TM) CATHETER INTRODUCER SYSTEM | Mar 24, 1988 | Substantially Equivalent |