FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
K Number: K872538
·
Decision Jul 10, 1987
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
13
Review Days
11
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Basic Information
- Device Name
- VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS
- K Number
- K872538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Vitaphore Corp.
- Date Received
- June 29, 1987
- Decision Date
- July 10, 1987
- Product Code
- JEC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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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 |
| K896046 | VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE | Jan 11, 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 |