FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT
K Number: K890751
·
Decision Apr 21, 1989
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
6
Review Days
67
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Basic Information
- Device Name
- ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT
- K Number
- K890751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medical Safety Products, Inc.
- Date Received
- February 13, 1989
- Decision Date
- April 21, 1989
- 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 Medical Safety Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942624 | LOK-ON NEEDLE DISPOSAL CONTAINER | Aug 25, 1994 | Substantially Equivalent |
| K913329 | V-ACCI-GUARD(TM) REUSABLE HOLDER | Aug 23, 1991 | Substantially Equivalent |
| K895075 | ACCI-GUARD REUSABLE HOLDER | Oct 31, 1989 | Substantially Equivalent |
| K884139 | ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER | Oct 6, 1988 | Substantially Equivalent |
| K881654 | ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE | Jul 8, 1988 | Substantially Equivalent |